protocol_id stringclasses 263
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NCT04620135 | 5.1.1 | Study Drug | 5.1.1 Study Drug Netarsudil mesylate ophthalmic solution is a sterile, isotonic, buffered aqueous solution containing netarsudil (0.02%), boric acid, mannitol, water for injection, and preserved with benzalkonium chloride (0.015%). The product formulations are adjusted to approximately pH 5. | [] |
NCT04620135 | 5.1.2 | Vehicle or Control Drug | 5.1.2 Vehicle or Control Drug Netarsudil ophthalmic solution vehicle is a sterile, isotonic, buffered aqueous solution containing boric acid, mannitol, water for injection, and preserved with benzalkonium chloride (0.015%). The product formulations are adjusted to approximately pH 5. As for control drug, ripasudil hydr... | [] |
NCT04620135 | 5.2 | Treatments Administered | 5.2 Treatments Administered Subjects will be randomized to receive investigational product (IP) netarsudil ophthalmic solution (0.02%) or ripasudil hydrochloride hydrate ophthalmic solution 0.4% administered 1 drop into each eye. Netarsudil ophthalmic solution 0.02% will be dosed QD (21:00) while ripasudil hydrochlorid... | [] |
NCT04620135 | 5.3 | Selection and Timing of Dose for Each Patient | 5.3 Selection and Timing of Dose for Each Patient Netarsudil ophthalmic solution 0.02% doses and treatment period selected for this study are based on two Phase 1 studies ([AR-13324-CS103](#page-64-1) and [AR-13324-CS104](#page-64-1)) and the results of the completed Phase 2 study in Japan [\(AR-13324-CS208](#page-65-0... | [] |
NCT04620135 | 5.4 | Method of Assigning Patients to Treatment Groups | 5.4 Method of Assigning Patients to Treatment Groups A randomization code for allocating the treatments will be prepared by an independent biostatistician who is not involved in the day-to-day conduct of the study. Subjects will be randomized using IWRS in a 1:1 ratio to receive netarsudil ophthalmic solution 0.02% or ... | [] |
NCT04620135 | 5.5 | Masking | 5.5 Masking Treatment assignments will be masked to the Investigator, the clinical study team (Sponsor personnel involved in day to day study management, Monitors, Data Managers, and Statisticians), and the subjects for the duration of the study. This study adopts a single-masked study design. Therefore, to ensure mask... | [] |
NCT04620135 | 5.6 | Concomitant Therapy | 5.6 Concomitant Therapy As noted in Section [5.7.1,](#page-27-1) subjects using ocular hypotensive medications at screening are required to undergo a washout of their current ocular hypotensive medications. Intermittent use of over-the-counter (OTC) artificial tear lubricant products is acceptable, with a minimum of 10... | [] |
NCT04620135 | 5.7 | Restrictions | 5.7 Restrictions | [] |
NCT04620135 | 5.7.1 | Prior Therapy/Washout Period | 5.7.1 Prior Therapy/Washout Period Subjects currently using ocular hypotensive medications must undergo a minimum washout period as specified in Table 1. If washout is to be extended beyond 8 weeks (56 days) for logistical or other reasons, the Sponsor should be contacted. Table 1 Ocular Hypotensive Medication Washout ... | [] |
NCT04620135 | 5.7.2 | Fluid and Food Intake | 5.7.2 Fluid and Food Intake On days that diurnal IOP measurements are made, subjects may not consume alcohol. Otherwise, there are no general restrictions on fluid or food intake for subjects participating in this study. | [] |
NCT04620135 | 5.7.3 | Subject Activity Restrictions | 5.7.3 Subject Activity Restrictions On days that diurnal IOP measurements are made, subjects may not engage in strenuous activity. In addition, eye dilation may cause blurred vision and temporary sensitivity to light. While pupils are dilated, subjects should protect eyes while in bright light by wearing sunglasses. Su... | [] |
NCT04620135 | 5.8 | Treatment Compliance | 5.8 Treatment Compliance All subjects will be instructed on the importance of following the twice-daily dosing regimen. Dosing should occur in the morning (9:00 ± 1 hour) and in the evening (21:00 ± 1 hour). As no commercially available method is readily available for direct, singlecontainer monitoring of treatment adh... | [] |
NCT04620135 | 5.9 | Packaging and Labeling | 5.9 Packaging and Labeling The container-closure systems for all products are multi-dose ophthalmic dropper dose bottles. The commercial label from ripasudil will be removed and replaced with an investigational label which will be similar in appearance for both treatment groups. The labeled bottles will be packaged in ... | [] |
NCT04620135 | 5.10 | Storage and Accountability | 5.10 Storage and Accountability The study treatments must be dispensed or administered according to the procedures prescribed in this protocol. Only subjects enrolled in the study may receive study treatment, in accordance with all the applicable regulatory requirements. Any study staff can dispense these medications. ... | [] |
NCT04620135 | 5.11 | Study drug Retention at Study Site | 5.11 Study drug Retention at Study Site | [] |
NCT04620135 | 5.11.1 | Receipt and Disposition of Study Medication | 5.11.1 Receipt and Disposition of Study Medication Study medication will be shipped to the Investigator's site from a central depot. The study medication storage manager at the Investigator's site will verify study medication shipment records by comparing the shipping documentation accompanying the study medication to ... | [] |
NCT04620135 | 5.11.2 | Return of Study Medication | 5.11.2 Return of Study Medication When the site is closed, the study is completed, or is terminated by the Sponsor; all study material including used and unused study medication will be returned to the Sponsor (or its designee). All study medication accounting procedures must be completed before the study is considered... | [] |
NCT04620135 | 6 | STUDY PROCEDURES | 6. STUDY PROCEDURES | [] |
NCT04620135 | 6.1 | Informed Consent | 6.1 Informed Consent Prior to any study procedures, the study will be discussed with each subject. Subjects wishing to participate must give written informed consent. The verbal explanation of the study will cover all the elements specified in the written information provided for the subject. The Investigator will info... | [] |
NCT04620135 | 6.2 | Demographics and Medical History | 6.2 Demographics and Medical History Demographic data and any ongoing medication use will be collected and recorded. Any medications the subject took but discontinued within the 30 days prior to screening will also be recorded. Significant medical history will be collected and any current underlying medical conditions,... | [] |
NCT04620135 | 6.3 | Concomitant Medication Assessments | 6.3 Concomitant Medication Assessments Use of all medications should be documented on the appropriate CRF. The site staff responsible for recording all concomitant medications will be identified on the Delegation of Responsibilities Log. Investigators are encouraged to contact the Sponsor/Sponsor representative for any... | [] |
NCT04620135 | 6.4 | Ophthalmic Assessment | 6.4 Ophthalmic Assessment The Investigator will review each subject's medical and ophthalmic history including systemic and ocular medication use to determine eligibility for this study. If enrolled, the Investigator will determine if there are any changes in health or concomitant medication use at each follow-up visit... | [] |
NCT04620135 | 6.5 | Vital Signs | 6.5 Vital Signs The Investigator or designee will measure heart rate, pulse, and blood pressure as described in the MOPs. | [] |
NCT04620135 | 6.6 | Pregnancy testing (for women of childbearing potential) | 6.6 Pregnancy testing (for women of childbearing potential) A urine human chorionic gonadotropin (hCG) pregnancy test (only for females who are not diagnosed as postmenopausal or surgically sterile) will be used in this study and performed at the screening visit to immediately confirm non-pregnancy eligibility for fema... | [] |
NCT04620135 | 6.7 | Study Eye Selection Process | 6.7 Study Eye Selection Process Subjects must qualify in the study eye based upon IOP, ocular history and exam. If the subject qualifies in only one eye, then this eye is designated the study eye. If the subject qualifies in both eyes, then the study eye will be the eye with the higher IOP at 09:00 hours on Visit 3. If... | [] |
NCT04620135 | 6.8 | Dispensing Study Drug | 6.8 Dispensing Study Drug Study staff responsible for dispensing study medication will be listed on the Delegation of Responsibilities Log. When a subject meets all criteria for selection and has completed all screening assessments, the subject will be assigned to a treatment group according to the IWRS. Any study staf... | [] |
NCT04620135 | 6.9 | Efficacy Assessments | 6.9 Efficacy Assessments | [] |
NCT04620135 | 6.9.1 | Specification of the Efficacy Parameters | 6.9.1 Specification of the Efficacy Parameters The primary efficacy outcome will be the comparison of netarsudil ophthalmic solution 0.02% relative to ripasudil hydrochloride hydrate ophthalmic solution 0.4% for mean diurnal IOP within a treatment at Week 4 (Day 29) by Goldmann Applanation Tonometry. Secondary efficacy... | [] |
NCT04620135 | 6.9.2 | Method and Timing for Assessing, Recording, and Analyzing of Efficacy Parameters | 6.9.2 Method and Timing for Assessing, Recording, and Analyzing of Efficacy Parameters As detailed in subsequent sections describing each visit and [Appendix 1,](#page-66-0) IOP will be measured at a screening visit, at 2 qualification visits after washout of ocular hypotensive medications as required, and at each post... | [] |
NCT04620135 | 6.9.3 | Intraocular Pressure | 6.9.3 Intraocular Pressure Local anesthetic will be applied in order to facilitate IOP measurements with the Goldmann Applanation Tonometer. Tonometer calibration on at least a monthly basis must be documented. Two consecutive IOP measurements of each eye must be obtained. If the 2 measurements differ by more than 2 mm... | [] |
NCT04620135 | 6.10 | Safety Assessments | 6.10 Safety Assessments The primary safety measures in both eyes of enrolled subjects will include: - Ocular symptoms/AEs - BCVA - Objective findings of biomicroscopic examinations (i.e., anterior segment examinations including evaluation of cornea, conjunctiva, lids, and lens) - Dilated ophthalmoscopy, including verti... | [] |
NCT04620135 | 6.10.1 | Best-Corrected Visual Acuity (BCVA) | 6.10.1 Best-Corrected Visual Acuity (BCVA) BCVA will be taken at visits as a measure of ocular function and will be measured at screening and frequently throughout the study. Visual acuity will be measured using Landolt-C chart or its equivalents. See MOPs for details of the procedures to be followed when determining B... | [] |
NCT04620135 | 6.10.2 | Biomicroscopy | 6.10.2 Biomicroscopy Biomicroscopic examination of the eyelids, conjunctiva, cornea, anterior chamber, lens, iris, and pupil will be carried out at every study visit for both eyes. Normal or abnormal status of these ocular tissues will be graded as described in the MOPs. | [] |
NCT04620135 | 6.10.2.1 | Corneal Deposit Grading under Biomicroscopy | 6.10.2.1 Corneal Deposit Grading under Biomicroscopy Subjects who are diagnosed with cornea verticillata by slit lamp examination will undergo the evaluation for its location and grading using a published grading scale for amiodaroneinduced cornea verticillata ([Orlando 1984](#page-63-3)). See the MOPs for the details ... | [] |
NCT04620135 | 6.10.3 | Gonioscopy/Pachymetry | 6.10.3 Gonioscopy/Pachymetry Gonioscopy will be used to confirm the iridocorneal angle is open and to what extent. Eligible subjects must have an angle of 3 or 4 (Shaffer grading scale; [Stamper 2009](#page-64-1)) for participation in the study. Gonioscopy may be performed up to 3 months prior to randomization. Pachyme... | [] |
NCT04620135 | 6.10.4 | Visual Field Testing | 6.10.4 Visual Field Testing Visual field testing must be performed in both eyes. Visual field testing may be performed up to 3 months prior to randomization. Visual fields must be determined as automated threshold perimetry (e.g., 30-2 or 24-2 Humphrey, Kowa etc.). SITA Standard is preferred, SITA fast or equivalent is... | [] |
NCT04620135 | 6.10.5 | Dilated Ophthalmoscopy | 6.10.5 Dilated Ophthalmoscopy A dilated funduscopic examination including evaluation of the retina, vitreous, macula, choroid, optic nerve, and vertical cup/disc ratio will be performed. See MOPs for further information on scoring. Evaluation of vertical cup-disc ratio will be performed when ophthalmoscopy is performed... | [] |
NCT04620135 | 6.11 | Adverse Events Assessments | 6.11 Adverse Events Assessments | [] |
NCT04620135 | 6.11.1 | Performing Adverse Event (AE) Assessments | 6.11.1 Performing Adverse Event (AE) Assessments Qualified study staff responsible for assessing AEs will be listed on the Delegation of Responsibilities Log. This includes assessment of AE severity and relationship to study medication. Adverse event information may be volunteered by the subject or solicited by study p... | [] |
NCT04620135 | 6.11.2 | Adverse Event Definition | 6.11.2 Adverse Event Definition The following definitions of terms apply to this section: - Adverse event (AE): Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. - Suspected adverse reaction (SAR): Any AE for which there is a reasonable possibility that... | [] |
NCT04620135 | 6.11.3 | Timing for Reporting of Adverse Events | 6.11.3 Timing for Reporting of Adverse Events The AEs occurring during the study must be documented, regardless of the assumption of a causal relationship. Adverse events should be documented from the time the subject receives the first dose of study medication until Week 4 [Day 29] or study discontinuation. If a subje... | [
"1. Action Taken with Study Drug:",
"2. Other Action Taken:",
"3. Outcome of an adverse event is coded as:"
] |
NCT04620135 | 6.11.4 | Severity | 6.11.4 Severity Severity of an AE is defined as a qualitative assessment of the level of discomfort or the degree of intensity of an AE as determined by the Investigator or reported to him/her by the subject. The assessment of severity is made irrespective of study medication relationship or seriousness of the event an... | [] |
NCT04620135 | 6.11.5 | Relationship | 6.11.5 Relationship The study medication relationship for each AE/adverse reaction should be determined by the Investigator using these explanations: - Not Related: The event is clearly related to other factors such as subject's clinical condition; therapeutic interventions, concomitant disease or therapy administered ... | [] |
NCT04620135 | 6.11.6 | Expectedness | 6.11.6 Expectedness The most frequently reported AE for netarsudil ophthalmic solution in two Phase 2 and four Phase 3 studies (Clinical Study Reports [AR-13324-CS205,](#page-64-1) [AR-13324-CS208,](#page-65-0) [AR-13324-CS301, AR-13324-CS302, AR-13324-CS303](#page-65-0) and [AR-13324-CS304](#page-65-0)) has been conju... | [] |
NCT04620135 | 6.11.7 | Serious Adverse Events (SAEs), Suspected Serious Adverse Reactions (SSARs), Suspected Unexpected Serious Adverse Reactions (SUSARs) | 6.11.7 Serious Adverse Events (SAEs), Suspected Serious Adverse Reactions (SSARs), Suspected Unexpected Serious Adverse Reactions (SUSARs) | [] |
NCT04620135 | 6.11.7.1 | Reporting SAEs or SSARs | 6.11.7.1 Reporting SAEs or SSARs An Investigator must immediately (i.e., within 24 hours) report any SAE or SSAR (see Section [6.11.2](#page-35-2) for definitions) to the representative of contract research organization (CRO) of the Sponsor (see Section 6.11.7.3 for contact information), whether or not the SAE or SSAR ... | [] |
NCT04620135 | 6.11.7.2 | Reporting SUSARs | 6.11.7.2 Reporting SUSARs The Investigator must immediately (i.e., within 24 hours) report SUSARs that occur or are observed during the course of the study or at the subject's last study visit. In the event of a SUSAR, the site must notify the representative of CRO of the Sponsor by telephone within 24 hours of knowled... | [] |
NCT04620135 | 6.11.7.3 | Safety Reporting Contact Information | 6.11.7.3 Safety Reporting Contact Information The Investigator must report an SAE, SSAR, or SUSAR occurring at his/her site to the representative of CRO of the Sponsor regardless of causality.  | [] |
NCT04620135 | 6.12 | Pregnancy Reporting | 6.12 Pregnancy Reporting Pregnancies occurring in subjects enrolled in the study or in their partners must be reported and followed to outcome. While pregnancy itself is not considered to be an AE or SAE, pregnancy reports are tracked by the representative of CRO of the Sponsor. Premature terminations including miscarr... | [] |
NCT04620135 | 6.13 | Removal of Subjects from the Study or Study Treatment | 6.13 Removal of Subjects from the Study or Study Treatment | [] |
NCT04620135 | 6.13.1 | Completed Subject | 6.13.1 Completed Subject A completed subject is defined as one who completes all planned study treatments and visits and completion of the post-treatment follow-up visit procedures. | [] |
NCT04620135 | 6.13.2 | Non-completing Subject | 6.13.2 Non-completing Subject A non-completing subject is defined as one who exits the study by their own volition or at the discretion of the Investigator, the Medical Monitor, and/or the Sponsor Safety Officer. Any subject may decide to voluntarily withdraw from the study at any time without prejudice. During the tre... | [] |
NCT04620135 | 6.13.3 | Actions after Discontinuation | 6.13.3 Actions after Discontinuation All subjects who discontinue study medication due to a report of an AE must be followed and provided appropriate medical care until their signs and symptoms have remitted or stabilized. For subjects who choose to withdraw consent or who are discontinued for non-compliance prior to c... | [] |
NCT04620135 | 6.13.4 | Discontinuation of the Entire Study | 6.13.4 Discontinuation of the Entire Study The entire study may be discontinued at a given site (by the Investigator or the Sponsor/ Sponsor representative or at all sites by the Sponsor). Prompt, written notice of reasonable cause to all other relevant parties (Sponsor or Investigator) is required. Prompt notice to th... | [] |
NCT04620135 | 6.13.5 | Completed Study | 6.13.5 Completed Study The study is completed when the planned enrollment has been completed, and all the enrolled subjects have completed the study. The Sponsor representative will be in communication with the Investigational sites regarding enrollment. | [] |
NCT04620135 | 6.14 | Appropriateness of Measurements | 6.14 Appropriateness of Measurements The ophthalmic and systemic measures used in this study are consistent with standard of care. In particular, IOP as measured by Goldmann applanation tonometry, the primary efficacy assessment in this study, is accepted worldwide as a standard for testing of pharmacologically active ... | [] |
NCT04620135 | 7 | STUDY ACTIVITIES | 7. STUDY ACTIVITIES The schedule of study visits and procedures is shown in [Appendix 1.](#page-66-0) | [] |
NCT04620135 | 7.1 | Visit 1 (Screening) | 7.1 Visit 1 (Screening) This visit may occur at any time of the day. The Investigator or a member of his/her staff will interview the individual as to their qualifications for participation in the study. Individuals will be asked to review the informed consent, discuss issues as needed, and to sign the form. A signed w... | [] |
NCT04620135 | 7.1.1 | Evaluation of Eye-Drop Instillation Performance | 7.1.1 Evaluation of Eye-Drop Instillation Performance Subjects (or legally authorized representative for subjects deemed unable to administer) will be provided a bottle of commercially available, multi-dose, non-medicated artificial tears in a room with access to water and soap. Medication instiller will be asked to in... | [] |
NCT04620135 | 7.1.2 | Washout | 7.1.2 Washout As noted in Section [5.7.1,](#page-27-1) a washout period is required for individuals currently using ocular hypotensive medications and who meet the other qualifications for enrollment. | [] |
NCT04620135 | 7.2 | Visit 2 (Qualification Visit #1, for IOP and safety measurements at 09:00 hours) | 7.2 Visit 2 (Qualification Visit #1, for IOP and safety measurements at 09:00 hours) After the washout (if needed), individuals will return to the Investigator's office in the early morning. The subject will be questioned regarding any changes in their health or concomitant medication use. Any change in the individual'... | [] |
NCT04620135 | 7.3 | Treatment Period | 7.3 Treatment Period | [] |
NCT04620135 | 7.3.1 | Visit 3.0 (Qualification Visit #2, Day 1, for IOP and safety measurements at 09:00 hours) | 7.3.1 Visit 3.0 (Qualification Visit #2, Day 1, for IOP and safety measurements at 09:00 hours) Within 2 to 7 days after Visit 2, individuals will return to the Investigator's office for the next 09:00 hour IOP measurement. The subject will be questioned regarding any changes in their health or concomitant medication u... | [] |
NCT04620135 | 7.3.2 | Visit 3.1 (Day 1, for IOP and safety measurements at 11:00 hours) | 7.3.2 Visit 3.1 (Day 1, for IOP and safety measurements at 11:00 hours) Inclusion/exclusion criteria will be reviewed again for the qualified individual. Qualified individuals will be examined. Each examination will include: - Symptomatology: Individuals will be asked "How are you feeling?" - A non-dilated eye examinat... | [] |
NCT04620135 | 7.3.3 | Visit 3.2 (Day 1, for IOP and safety measurements at 16:00 hours) | 7.3.3 Visit 3.2 (Day 1, for IOP and safety measurements at 16:00 hours) Inclusion/exclusion criteria will be reviewed again for the qualified individual. Qualified individuals will be examined. Each examination will include: - Symptomatology: Individuals will be asked "How are you feeling?" - A non-dilated eye examinat... | [
"Subjects will be:"
] |
NCT04620135 | 7.3.4 | Visit 4.0 (Week 1 [Day 8], for IOP and safety measurements at 09:00 hours) | 7.3.4 Visit 4.0 (Week 1 [Day 8], for IOP and safety measurements at 09:00 hours) Subjects will return to the Investigator's office. The subject will be questioned about any missed doses and any changes in their health or concomitant medication use. Subjects will be examined, and each examination will include: - Heart r... | [
"Subjects are allowed to administer their masked medication after IOP measurements."
] |
NCT04620135 | 7.3.5 | Visit 4.1 (Week 1 [Day 8], for IOP and safety measurements at 11:00 hours) | 7.3.5 Visit 4.1 (Week 1 [Day 8], for IOP and safety measurements at 11:00 hours) Subjects will be examined, and each examination will include: - Symptomatology: Individuals will be asked "How are you feeling?" - Recording of any AEs - A non-dilated eye examination will be performed, including IOP measurements and biomi... | [] |
NCT04620135 | 7.3.6 | Visit 4.2 (Week 1 [Day 8], for IOP and safety measurements at 16:00 hours) | 7.3.6 Visit 4.2 (Week 1 [Day 8], for IOP and safety measurements at 16:00 hours) Subjects will be examined, and each examination will include: • Symptomatology: Individuals will be asked "How are you feeling?" - Recording of any AEs. - A non-dilated eye examination will be performed, including IOP measurements and biom... | [
"Subjects will be:"
] |
NCT04620135 | 7.3.7 | Visit 5.0 (Week 2 [Day 15], for IOP and safety measurements at 09:00 hours) | 7.3.7 Visit 5.0 (Week 2 [Day 15], for IOP and safety measurements at 09:00 hours) Subjects will return to the Investigator's office. The subject will be questioned regarding any missed doses and any changes in their health or concomitant medication use. Subjects will be examined, and each examination will include: - He... | [
"Subjects are allowed to administer their masked medication after IOP measurements."
] |
NCT04620135 | 7.3.8 | Visit 5.1 (Week 2 [Day 15], for IOP and safety measurements at 11:00 hours) | 7.3.8 Visit 5.1 (Week 2 [Day 15], for IOP and safety measurements at 11:00 hours) Subjects will be examined, and each examination will include: - Symptomatology: Individuals will be asked "How are you feeling?" - Recording of any AEs - A non-dilated eye examination will be performed, including IOP measurements and biom... | [] |
NCT04620135 | 7.3.9 | Visit 5.2 (Week 2 [Day 15], for IOP and safety measurements at 16:00 hours) | 7.3.9 Visit 5.2 (Week 2 [Day 15], for IOP and safety measurements at 16:00 hours) Subjects will be examined, and each examination will include: - Symptomatology: Individuals will be asked "How are you feeling?" - Recording of any AEs - A non-dilated eye examination will be performed, including IOP measurements and biom... | [] |
NCT04620135 | 7.3.10 | Visit 6.0 (Week 4 [Day 29], for IOP and safety measurements at 09:00 hours) | 7.3.10 Visit 6.0 (Week 4 [Day 29], for IOP and safety measurements at 09:00 hours) Subjects will return to the Investigator's office. The subject will be questioned about any missed doses and any changes in their health or concomitant medication use. Subjects will be examined, and each examination will include: - Heart... | [] |
NCT04620135 | 7.3.11 | Visit 6.1 (Week 4 [Day 29], for IOP and safety measurements at 11:00 hours) | 7.3.11 Visit 6.1 (Week 4 [Day 29], for IOP and safety measurements at 11:00 hours) Subjects will be examined, and each examination will include: - Symptomatology: Individuals will be asked "How are you feeling?" - Recording of any AEs - A non-dilated eye examination will be performed, including IOP measurements and bio... | [] |
NCT04620135 | 7.3.12 | Visit 6.2 (Week 4 [Day 29], for IOP and safety measurements at 16:00 hours) | 7.3.12 Visit 6.2 (Week 4 [Day 29], for IOP and safety measurements at 16:00 hours) Subjects will be examined, and each examination will include: - Symptomatology: Individuals will be asked "How are you feeling?" - Recording of any AEs - A non-dilated eye examination will be performed, including IOP measurements and bio... | [] |
NCT04620135 | 7.4 | Unscheduled Visits | 7.4 Unscheduled Visits An unscheduled visit may be any visit to the Investigator other than the specific visits requested in the protocol as possibly required for the subject's ophthalmic condition. The Investigator will perform all procedures necessary to evaluate the study participant at these visits and record any A... | [] |
NCT04620135 | 8 | QUALITY CONTROL AND ASSURANCE | 8. QUALITY CONTROL AND ASSURANCE The progress of the study will be monitored by on-site, written, remote review, and telephone communications between personnel at the Investigator's site and the Study Monitor. The Investigator will allow the Sponsor or its designee to inspect all CRFs; patient record (source documents)... | [] |
NCT04620135 | 9 | PLANNED STATISTICAL METHODS | 9. PLANNED STATISTICAL METHODS | [] |
NCT04620135 | 9.1 | General Considerations | 9.1 General Considerations Summaries will be presented by treatment, visit, and time point (as applicable). Continuous and ordinal study assessments will be summarized using descriptive statistics (n, mean, median, standard deviation, minimum, and maximum). Discrete study assessments will be summarized using frequency ... | [] |
NCT04620135 | 9.2 | Hypotheses | 9.2 Hypotheses H0: The difference in mean diurnal IOP in study eyes treated with netarsudil QD versus study eyes treated with ripasudil BID (netarsudil QD – ripasudil BID) at Week 4 = 0. H1: The difference in mean diurnal IOP in study eyes treated with netarsudil QD versus study eyes treated with ripasudil BID (netarsu... | [] |
NCT04620135 | 9.3 | Adjustments for Multiplicity | 9.3 Adjustments for Multiplicity No adjustment for multiplicity is required for this study with a single primary endpoint and no secondary endpoints identified for labeling claims. | [] |
NCT04620135 | 9.4 | Determination of Sample Size | 9.4 Determination of Sample Size Ninety three (93) subjects (study eyes) per treatment group are required to have 90% power (1-β) to reject H0 in favor of H1 at a two-sided significance level of 5%, assuming that a difference of the change from baseline in mean diurnal IOP (netarsudil QD – ripasudil BID) in the propose... | [] |
NCT04620135 | 9.5 | Analysis Populations | 9.5 Analysis Populations | [] |
NCT04620135 | 9.5.1 | Intent-to-Treat (ITT) Population | 9.5.1 Intent-to-Treat (ITT) Population The ITT population will include all randomized subjects who have received at least 1 dose of study medication. This population will be the primary population for efficacy analyses and will be used to summarize all efficacy variables and will summarize subjects as randomized. | [] |
NCT04620135 | 9.5.2 | Per Protocol (PP) Population | 9.5.2 Per Protocol (PP) Population The per protocol (PP) population is a subset of the ITT population, which will include those subjects who do not have major protocol violations likely to seriously affect the primary outcome of the study as judged by a masked evaluation prior to the unmasking of the study treatment. T... | [] |
NCT04620135 | 9.5.3 | Safety Population | 9.5.3 Safety Population The safety population will include all randomized subjects who have received at least 1 dose of study medication. This population will be used to summarize safety variables and will summarize subjects as treated. | [] |
NCT04620135 | 9.6 | Demographics and Baseline Characteristics | 9.6 Demographics and Baseline Characteristics Demographic and baseline characteristics such as age, gender, or disease status will be summarized and listed. Medical history, history of ocular surgery and procedures, glaucoma history and washout period (if needed) will also be summarized and listed. | [] |
NCT04620135 | 9.7 | Primary Efficacy | 9.7 Primary Efficacy | [] |
NCT04620135 | 9.7.1 | Primary Efficacy Endpoint(s) | 9.7.1 Primary Efficacy Endpoint(s) The primary efficacy endpoint will be the comparison of netarsudil ophthalmic solution 0.02% relative to ripasudil hydrochloride hydrate ophthalmic solution 0.4% for mean diurnal IOP within a treatment group at Week 4 (Day 29) by Goldmann Applanation Tonometry. | [] |
NCT04620135 | 9.7.2 | Primary Efficacy Analyses | 9.7.2 Primary Efficacy Analyses The primary analysis of the primary endpoint will employ a linear model with mean diurnal IOP at Week 4 as the response, baseline mean diurnal IOP as a covariate, and treatment as a main effect factor, using the ITT population with Monte Carlo Markov Chain and regression based multiple i... | [] |
NCT04620135 | 9.8 | Secondary Efficacy | 9.8 Secondary Efficacy | [] |
NCT04620135 | 9.8.1 | Secondary Efficacy Endpoints | 9.8.1 Secondary Efficacy Endpoints - Mean diurnal IOP at Weeks 1 and 2 (Days 8 and 15, respectively) - Mean change from baseline in mean diurnal IOP at each post-treatment visit - Mean percent change from baseline in mean diurnal IOP at each post-treatment visit - Mean IOP at each post-treatment time point - Mean chang... | [] |
NCT04620135 | 9.8.2 | Secondary Efficacy Analyses | 9.8.2 Secondary Efficacy Analyses Secondary analyses of the primary efficacy endpoint include repeating the primary analysis strategy using: observed data only, last observation carried forward (LOCF) where LOCF will be performed using time-relevant measures, and using worst on treatment time-relevant observation withi... | [] |
NCT04620135 | 9.9 | Safety | 9.9 Safety | [] |
NCT04620135 | 9.9.1 | Safety Endpoints | 9.9.1 Safety Endpoints The primary safety measures in both eyes of enrolled subjects will include: - Ocular symptoms/AEs - BCVA - Objective findings of biomicroscopic examinations (i.e., anterior segment examinations including evaluation of cornea, conjunctiva, lids, and lens) - Dilated ophthalmoscopy, including vertic... | [] |
NCT04620135 | 9.9.2 | Safety Analyses | 9.9.2 Safety Analyses Verbatim descriptions of AEs will be mapped to MedDRA/J thesaurus terms and be presented in a data listing. Treatment emergent AEs (TEAEs), those that occur or worsen after the first dose of study medication, will be summarized by treatment group using frequency and percent for each system organ c... | [] |
NCT04620135 | 9.10 | Other Assessments or Analyses | 9.10 Other Assessments or Analyses Other assessments or analyses will be described in the statistical analysis plan as appropriate. | [] |
NCT04620135 | 9.11 | Interim Analysis | 9.11 Interim Analysis No interim analysis is planned for this study. | [] |
NCT04620135 | 10 | ADMINISTRATIVE CONSIDERATIONS | 10. ADMINISTRATIVE CONSIDERATIONS | [] |
NCT04620135 | 10.1 | Investigators and Study Administrative Structure | 10.1 Investigators and Study Administrative Structure The Principal Investigator is responsible for all site medical-related decisions. The qualified sponsor Medical Monitor is responsible for the safety conduct of this study:  | [] |
NCT04620135 | 10.2 | Institutional Review Board or Independent Ethics Committee Approval | 10.2 Institutional Review Board or Independent Ethics Committee Approval This study is to be conducted in accordance with IRB or IEC regulations and ICH-GCP and J-GCP. The protocol, protocol amendments, informed consent form, and all documents that will be provided to subjects (e.g., subject diary, subject dosing instr... | [] |
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