protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT04102098 | 6.10.1 | Interim Analyses of RFS | 6.10.1 Interim Analyses of RFS One interim analysis of IRF-assessed RFS will be performed. The interim analysis will be performed when approximately 236 RFS events have occurred, which is expected to take place approximately 26 months after the first patient is randomized. For the interim analysis, the MDD for RFS is a... | [] |
NCT04102098 | 6.10.2 | Interim Analyses of OS | 6.10.2 Interim Analyses of OS A group sequential design will be implemented for testing OS to account for the conduct of up to two interim analyses. The boundary for statistical significance at each interim analysis and the final analysis will be determined based on the Lan-DeMets implementation of the O'Brien-Fleming ... | [] |
NCT04102098 | 6.11 | CHINA SUBPOPULATION ANALYSES | 6.11 CHINA SUBPOPULATION ANALYSES The Sponsor is targeting a total enrollment of a minimum of 250 patients from mainland China. The sample size of the China subpopulation was determined by characterizing the efficacy and safety profile of atezolizumab plus bevacizumab. After approximately 662 patients have been randomi... | [] |
NCT04102098 | 7 | DATA COLLECTION AND MANAGEMENT | 7. DATA COLLECTION AND MANAGEMENT | [] |
NCT04102098 | 7.1 | DATA QUALITY ASSURANCE | 7.1 DATA QUALITY ASSURANCE The Sponsor will be responsible for data management of this study, including quality checking of the data. Data entered manually will be collected via EDC through use of eCRFs. Sites will be responsible for data entry into the EDC system. In the event of discrepant data, the Sponsor will requ... | [] |
NCT04102098 | 7.2 | ELECTRONIC CASE REPORT FORMS | 7.2 ELECTRONIC CASE REPORT FORMS The eCRFs are to be completed through use of a Sponsor-designated EDC system. Sites will receive training and have access to a manual for appropriate eCRF completion. The eCRFs will be submitted electronically to the Sponsor and should be handled in accordance with instructions from the... | [] |
NCT04102098 | 7.3 | SOURCE DATA DOCUMENTATION | 7.3 SOURCE DATA DOCUMENTATION Study monitors will perform ongoing source data verification and review to confirm that critical protocol data (i.e., source data) entered into the eCRFs by authorized site personnel are accurate, complete, and verifiable from source documents. Source documents (paper or electronic) are th... | [] |
NCT04102098 | 7.4 | USE OF COMPUTERIZED SYSTEMS | 7.4 USE OF COMPUTERIZED SYSTEMS When clinical observations are entered directly into a study site's computerized medical record system (i.e., in lieu of original hardcopy records), the electronic record can serve as the source document if the system has been validated in accordance with health authority requirements pe... | [] |
NCT04102098 | 7.5 | RETENTION OF RECORDS | 7.5 RETENTION OF RECORDS Records and documents pertaining to the conduct of this study and the distribution of IMP, including eCRFs, electronic or paper PRO data (if applicable), Informed Consent Forms, laboratory test results, and medication inventory records, must be retained by the Principal Investigator for 15 year... | [] |
NCT04102098 | 8 | ETHICAL CONSIDERATIONS | 8. ETHICAL CONSIDERATIONS | [] |
NCT04102098 | 8.1 | COMPLIANCE WITH LAWS AND REGULATIONS | 8.1 COMPLIANCE WITH LAWS AND REGULATIONS This study will be conducted in full conformance with the ICH E6 guideline for Good Clinical Practice and the principles of the Declaration of Helsinki, or the applicable laws and regulations of the country in which the research is conducted, whichever affords the greater protec... | [] |
NCT04102098 | 8.2 | INFORMED CONSENT | 8.2 INFORMED CONSENT The Sponsor's sample Informed Consent Form (and ancillary sample Informed Consent Forms such as an Assent Form or Mobile Nursing Informed Consent Form, if applicable) will be provided to each site. If applicable, it will be provided in a certified translation of the local language. The Sponsor or i... | [] |
NCT04102098 | 8.3 | INSTITUTIONAL REVIEW BOARD OR ETHICS COMMITTEE | 8.3 INSTITUTIONAL REVIEW BOARD OR ETHICS COMMITTEE This protocol, the Informed Consent Forms, any information to be given to the patient, and relevant supporting information must be submitted to the IRB/EC by the Principal Investigator and reviewed and approved by the IRB/EC before the study is initiated. In addition, ... | [] |
NCT04102098 | 8.4 | CONFIDENTIALITY | 8.4 CONFIDENTIALITY Information technology systems used to collect, process, and store study- related data are secured by technical and organizational security measures designed to protect such data against accidental or unlawful loss, alteration, or unauthorized disclosure or access. In the event of a data security br... | [] |
NCT04102098 | 8.5 | FINANCIAL DISCLOSURE | 8.5 FINANCIAL DISCLOSURE Investigators will provide the Sponsor with sufficient, accurate financial information in accordance with local regulations to allow the Sponsor to submit complete and accurate financial certification or disclosure statements to the appropriate health authorities. Investigators are responsible ... | [] |
NCT04102098 | 9 | STUDY DOCUMENTATION, MONITORING, AND ADMINISTRATION | 9. STUDY DOCUMENTATION, MONITORING, AND ADMINISTRATION | [] |
NCT04102098 | 9.1 | STUDY DOCUMENTATION | 9.1 STUDY DOCUMENTATION The investigator must maintain adequate and accurate records to enable the conduct of the study to be fully documented, including, but not limited to, the protocol, protocol amendments, Informed Consent Forms, and documentation of IRB/EC and governmental approval. In addition, at the end of the ... | [] |
NCT04102098 | 9.2 | PROTOCOL DEVIATIONS | 9.2 PROTOCOL DEVIATIONS The investigator should document and explain any protocol deviations. The investigator should promptly report any deviations that might have an impact on patient safety and data integrity to the Sponsor and to the IRB/EC in accordance with established IRB/EC policies and procedures. The Sponsor ... | [] |
NCT04102098 | 9.3 | MANAGEMENT OF STUDY QUALITY | 9.3 MANAGEMENT OF STUDY QUALITY The Sponsor will implement a system to manage the quality of the study, focusing on processes and data that are essential to ensuring patient safety and data integrity. The Sponsor will identify potential risks associated with critical trial processes and data and will implement plans fo... | [] |
NCT04102098 | 9.4 | SITE INSPECTIONS | 9.4 SITE INSPECTIONS Site visits will be conducted by the Sponsor or an authorized representative for inspection of study data, patients' medical records, and eCRFs. The investigator will permit national and local health authorities; Sponsor monitors, representatives, and collaborators; and the IRBs/ECs to inspect faci... | [] |
NCT04102098 | 9.5 | ADMINISTRATIVE STRUCTURE | 9.5 ADMINISTRATIVE STRUCTURE This trial will be sponsored and managed by F. Hoffmann-La Roche Ltd. The Sponsor will provide clinical operations management, data management, and medical monitoring. Approximately 175 sites globally will participate to randomize approximately 662 patients. Screening and enrollment will oc... | [] |
NCT04102098 | 9.6 | DISSEMINATION OF DATA AND PROTECTION OF TRADE SECRETS | 9.6 DISSEMINATION OF DATA AND PROTECTION OF TRADE SECRETS Regardless of the outcome of a trial, the Sponsor is dedicated to openly providing information on the trial to healthcare professionals and to the public, at scientific congresses, in clinical trial registries, and in peer-reviewed journals. The Sponsor will com... | [] |
NCT04102098 | 9.7 | PROTOCOL AMENDMENTS | 9.7 PROTOCOL AMENDMENTS Any protocol amendments will be prepared by the Sponsor. Protocol amendments will be submitted to the IRB/EC and to regulatory authorities in accordance with local regulatory requirements. Approval must be obtained from the IRB/EC and regulatory authorities (as locally required) before implement... | [] |
NCT04102098 | 10 | REFERENCES | 10. REFERENCES - Aaronson NK, Ahmedzai S, Bergman B, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993;85:36576. - Antonia SJ, Villegas A, Daniel D, at al. Durvalumab after chemoradiot... | [
"Appendix 1 Schedule of Activities",
"Appendix 1: Schedule of Activities (cont.) Atezolizumab and Bevacizumab—F. Hoffmann-La Roche Ltd imaging assessment after the treatment/surveillance period. The visit window for the LTFU is 21 days. If the patient withdraws from study, the study staff may use a public informa... |
NCT04111965 | 1 | Summary | 1. Summary | [] |
NCT04111965 | 1.1 | Synopsis | 1.1 Synopsis | Title of the study: | | | | | |-------------------------------------------------------------------------------------------|--|--|--|--| | Phase I-II clinical study to compare the safety and efficacy of Nanodrop® versus Systane® | | | | | | Balance in the treatment of patients with dry eye | | | | | | Cre... | [
"Goals:",
"Security:",
"Effectiveness:",
"Hypothesis:",
"Security:",
"Effectiveness:",
"Study design:",
"Inclusion criteria:",
"Exclusion criteria:",
"Research Products (RP):",
"Investigational product, dosage and route of administration:",
"Comparator product, dose and route of administration... |
NCT04111965 | 1.2 | Study diagram | 1.2 Study diagram  VB= Baseline visit V1= Visit 1. Safety visit. VF= Final visit. Assessment of final outcome variables. Ll S= Safety call | [] |
NCT04111965 | 1.3 | Study schedule | 1.3 Study schedule | | VB | V1 | VF | LLS | |-------------------------------------------------------------------------------------|-----|------------|------------|----------| | PROCEDURES | D 1 | D 8 to ± 1 | D 29 to +1 | D 35 ± 1 | | FCI Signature | X | | | | | Medical record | X | | | | | Vital signs | X | X | X | | ... | [] |
NCT04111965 | 2 | Introduction and Background | 2. Introduction and Background | [] |
NCT04111965 | 2.1 | Theoretical framework | 2.1 Theoretical framework Dry eye is currently defined as a multifactorial ocular surface disease characterized by a loss of tear film homeostasis accompanied by ocular symptoms, in which ocular surface instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiologi... | [
"+ Detailed eye examination",
"Table 1Triage questions",
"Stage 1:",
"Stage 2:",
"Stage 3:",
"Stage 4:",
"Table 2Stages of dry eye treatment"
] |
NCT04111965 | 2.2 | Background on the product under study | 2.2 Background on the product under study | [] |
NCT04111965 | 2.2.1 | Pharmacology of the investigational product | 2.2.1 Pharmacology of the investigational product Propylene glycol is considered a demulcent or humectant in ophthalmic lubricant formulations. These agents are used to lubricate the ocular surface, thereby helping to reduce associated discomfort and irritation. Propylene glycol is a colorless, viscous, water-soluble p... | [] |
NCT04111965 | 2.2.2 | Product efficacy under investigation | 2.2.2 Product efficacy under investigation Propylene glycol's effectiveness as a humectant is based on its ability to retain water, up to three times its own weight, [20]combined with the previously mentioned characteristics conferred by its nanoemulsion formulation. There is no information yet on the efficacy of Nanod... | [] |
NCT04111965 | 2.2.3 | Safety of the investigational product | 2.2.3 Safety of the investigational product The U.S. Food and Drug Administration (FDA) has determined that propylene glycol is "generally regarded as safe" (GRAS) for use in food, cosmetics, and drug products. In addition, the FDA created a monograph in the late 1980s considering the wide variety of components present... | [] |
NCT04111965 | 2.2.4 | Summary of the pharmaceutical development of the investigational product | 2.2.4 Summary of the pharmaceutical development of the investigational product Nanodrop® was developed by Laboratorios Sophia, SA de CV. It has physicochemical characterization and an accelerated and long-term stability protocol. A preclinical safety and toxicity study was conducted in New Zealand albino rabbits, with ... | [] |
NCT04111965 | 2.3 | Background on the research | 2.3 Background on the research | [] |
NCT04111965 | 2.3.1 | From the research question | 2.3.1 From the research question There is no prior clinical trial data on Nanodrop®. However, the efficacy and tolerability of Systane® Balance have been previously evaluated in three single-center clinical studies. [22, 23, 24]Systane® Balance is the comparator for the present study. It shares with Nanodrop® the use o... | [] |
NCT04111965 | 2.4 | Risk benefit assessment | 2.4 Risk benefit assessment | [] |
NCT04111965 | 2.4.1 | Known potential risks | 2.4.1 Known potential risks Ocular lubricants are safe formulations. Propylene glycol has a known safety profile. The diagnostic tests considered in the study design are also considered safe. The only anticipated side effects with ophthalmic applications are burning, a foreign body sensation, and blurred vision. These ... | [] |
NCT04111965 | 2.4.2 | Known potential benefits | 2.4.2 Known potential benefits Potential benefits include relief of symptoms associated with dry eye and the likely restoration of tear film homeostasis. | [] |
NCT04111965 | 2.5 | Problem statement | 2.5 Problem statement Although the pathogenesis of dry eye is multiple and its semiotics variable, the different treatment phases have a common denominator: the use of ocular lubricants. There is a wide variety of topical lubricants, with different moisturizing agents; however, there is no evidence that one is better t... | [] |
NCT04111965 | 2.6 | Justification | 2.6 Justification Patients with dry eye, regardless of its etiology and severity, will need to use ocular lubricants to reduce symptoms and improve their quality of life. Ocular lubricants are the first-line treatment for ocular symptoms related to dry eye in selfreportedly healthy subjects, with a prevalence of 5% to ... | [] |
NCT04111965 | 3 | Objectives and hypotheses | 3. Objectives and hypotheses | [] |
NCT04111965 | 3.1 | Primary objectives | 3.1 Primary objectives | [] |
NCT04111965 | 3.1.1 | Primary security objective | 3.1.1 Primary security objective To evaluate the safety of ophthalmic application of Nanodrop® by quantifying the incidence of unexpected Adverse Events (AEs). | [] |
NCT04111965 | 3.1.2 | Primary efficacy objective | 3.1.2 Primary efficacy objective To demonstrate the non-inferiority of Nanodrop® compared to Systane® Balance in the treatment efficacy of patients with dry eye, using the OSDI (Ocular Surface Disease Index) test score. | [] |
NCT04111965 | 3.2 | Secondary objectives | 3.2 Secondary objectives | [] |
NCT04111965 | 3.2.1 | Secondary security objective | 3.2.1 Secondary security objective To compare the safety of ophthalmic application of Nanodrop® versus Systane® Balance by quantifying the incidence of expected adverse events. | [] |
NCT04111965 | 3.2.2 | Secondary efficacy objectives | 3.2.2 Secondary efficacy objectives To compare the efficacy of ophthalmic application of Nanodrop® versus Systane® Balance through changes in BCVA. To compare the efficacy of ophthalmic application of Nanodrop® versus Systane® Balance by changes in conjunctival staining with lissamine green. To compare the efficacy of ... | [] |
NCT04111965 | 3.3 | Exploratory objectives | 3.3 Exploratory objectives Compare the average daily applications of Nanodrop® versus Systane® Balance. | [] |
NCT04111965 | 3.4 | Hypothesis | 3.4 Hypothesis | [] |
NCT04111965 | 3.4.1 | Security hypothesis | 3.4.1 Security hypothesis H 0 =Nanodrop® is safe in its ophthalmic application, presenting an incidence of unexpected AEs, related to the PI less than 20% of the population of the Nanodrop® safety group H 1 = Nanodrop® is not safe for ophthalmic application, as it presents an incidence of unexpected AEs related to the ... | [] |
NCT04111965 | 3.4.2 | Efficacy hypothesis | 3.4.2 Efficacy hypothesis H 0 = Nanodrop® is inferior to Systane® Balance by more than 5 points on the OSDI test score $$H0: \muA - \muB > \delta$$ H 1 = Nanodrop® is inferior to Systane® Balance by 5 points or less on the OSDI test score $$H1: \muA - \muB \leq \delta$$ | [] |
NCT04111965 | 4 | Study design | 4. Study design | [] |
NCT04111965 | 4.1 | Design Overview | 4.1 Design Overview Phase I-II, comparative, non-inferiority, active-controlled, parallel-group, double-blind, randomized clinical trial. Safety analysis is performed upon completion of the first 12 subjects in the Nanodrop® group. If fewer than 20% of unexpected AEs related to the investigational product occur, recrui... | [] |
NCT04111965 | 4.2 | Justification of the study design | 4.2 Justification of the study design Propylene glycol, a component of Nanodrop®, is a compound classified by the FDA as GRAS for use in food, cosmetics, and drug products. The propylene glycol concentration falls within the specifications of the FDA monograph for ophthalmic lubricants considered safe. Because of this,... | [] |
NCT04111965 | 4.3 | Expected duration | 4.3 Expected duration The total duration of the study, from the first patient visit to the final report, is estimated to be 11 months. The planned recruitment period is 9 months. Considering the proposed sample size of 126 subjects, the average recruitment rate throughout the study should be no less than 0.5 subjects p... | [] |
NCT04111965 | 5 | Study population | 5. Study population | [] |
NCT04111965 | 5.1 | Eligibility criteria | 5.1 Eligibility criteria | [] |
NCT04111965 | 5.1.1 | Inclusion criteria | 5.1.1 Inclusion criteria - − Have the ability to voluntarily grant signed informed consent. - − Be able and willing to comply with scheduled visits, treatment plan, and other study procedures. - − Be willing to modify your lifestyle activities. See 5.3 [Lifestyle considerations.](#page-28-3) - − Be of age. - − Women of... | [] |
NCT04111965 | 5.1.2 | Exclusion criteria | 5.1.2 Exclusion criteria - − For women: be pregnant, breastfeeding, or planning to become pregnant during the study period. - − Having participated in another clinical research study ≤ 30 days prior to the screening visit. - − Having previously participated in this study. - − Present a BCVA of 20/200 or worse in either... | [] |
NCT04111965 | 5.2 | Criteria for eliminating and replacing subjects | 5.2 Criteria for eliminating and replacing subjects | [] |
NCT04111965 | 5.2.1 | Elimination criteria | 5.2.1 Elimination criteria - − Withdrawal of the FCI letter. - − Presentation of a serious adverse event, whether or not related to the investigational product, which, in the opinion of the PI and/or the sponsor, could affect the patient's ability to safely continue study procedures. - − Non-tolerability or hypersensit... | [] |
NCT04111965 | 5.3.1 | Substitution of subjects | 5.3.1 Substitution of subjects The sponsor, with prior authorization from the research ethics committees, may decide to replace subjects who withdraw their FCI or those who are lost to follow-up, if it is necessary to balance the study groups so that they are evaluable, or to complete the minimum population to be evalu... | [] |
NCT04111965 | 5.3 | Lifestyle considerations | 5.3 Lifestyle considerations For the study, participants may need to modify some lifestyle activities to accomplish the following: - Refrain from smoking. - Refrain from using electronic vaporizers. - Avoid immersing yourself in water without eye protection ( goggles ). - Avoid direct exposure to fans (including air co... | [] |
NCT04111965 | 5.4 | Scrutiny failures | 5.4 Scrutiny failures A screening failure is defined as a participant who agrees to participate in the study, giving their consent, but who is not assigned to a treatment group; that is, they do not enter the study. The following information regarding screening failures must be reported, at a minimum: - Demographic dat... | [] |
NCT04111965 | 5.5 | Recruitment and retention strategies | 5.5 Recruitment and retention strategies This is a Phase I-II study planned for six centers. The selected centers will be responsible for subject recruitment. Recruitment will be competitive, with a proposed initial recruitment of 21 subjects per center; however, this will be contingent on the performance of each cente... | [] |
NCT04111965 | 5.6 | Procedure in case of loss of follow-up | 5.6 Procedure in case of loss of follow-up For this protocol, loss to follow-up is defined as those subjects who were randomized, who at some point were active subjects in the study, but their final evaluation could not be completed. If the participating subject does not attend their appointment, the research site will... | [] |
NCT04111965 | 5.7 | Subject identification | 5.7 Subject identification Study subjects will be identified by a number and the initials of their name. The initials of the subject of study will be obtained starting with the first letter of the name, followed by the first letter of the first surname and the first letter of the second surname, obtaining a maximum of ... | [
"Example:",
"Example:"
] |
NCT04111965 | 6 | Investigational product | 6. Investigational product | [] |
NCT04111965 | 6.1 | Managed Products | 6.1 Managed Products | [] |
NCT04111965 | 6.1.1 | Investigational product | 6.1.1 Investigational product - − Generic name: Propylene glycol - − Distinguishing name: Nanodrop® (PRO-176) - − Active ingredients: Propylene glycol 0.6%. - − Pharmaceutical form: Ophthalmic emulsion - − Presentation: multi-dose dropper bottle, 10 ml. - − Prepared by: Laboratorios Sophia, SA de CV - − Solution descri... | [] |
NCT04111965 | 6.1.2 | Reference product | 6.1.2 Reference product - − Generic name: Propylene glycol - − Distinguishing name: Systane® Balance - − Active ingredients: Propylene glycol 0.6% - − Pharmaceutical form: Ophthalmic emulsion - − Presentation: multi-dose dropper bottle, 10 ml. - − Manufactured by: Alcon Laboratories, Inc. | [] |
NCT04111965 | 6.1.2.1 | Justification of the reference product | 6.1.2.1 Justification of the reference product Systane® Balance is a commercially available lubricant with a previously described safety and efficacy profile. It is a propylene glycol ophthalmic emulsion at the same concentration as Nanodrop®. Furthermore, it will be a direct commercial competitor. | [] |
NCT04111965 | 6.1.3 | Dosage of investigational products | 6.1.3 Dosage of investigational products The minimum dosage to follow is 1 drop, four times a day, in both eyes. However, subjects may increase the number of applications, if they deem necessary, as many times per day as they deem necessary. Each application must be recorded in the "Subject Diary." | [] |
NCT04111965 | 6.1.3.1 | Justification of the dose | 6.1.3.1 Justification of the dose Ophthalmic lubricants are generally prescribed as needed (pro re nata [PRN]). [28]However, the study by Asbell et al. compared the efficacy of QID versus PRN dosing. Their results showed that, although there was no difference in clinical signs, the QID group had greater symptom improve... | [] |
NCT04111965 | 6.2 | Storage and handling of research products at the study center | 6.2 Storage and handling of research products at the study center Delivery will be made via a courier service contracted by the sponsor, specifically selected for this purpose, to the address of the research center in accordance with the study plan. Reception will be carried out by the assigned research team staff. The... | [] |
NCT04111965 | 6.3 | Concomitant treatments and medications not authorized during the study | 6.3 Concomitant treatments and medications not authorized during the study Subjects successfully enrolled in the study and who meet the eligibility criteria may continue systemic treatment for their underlying conditions. If they require the introduction of a new approved medication during the course of the study, they... | [
"Permitted medications:",
"Prohibited medications:"
] |
NCT04111965 | 6.4 | Procedure for monitoring and measuring adherence | 6.4 Procedure for monitoring and measuring adherence For more than four decades, numerous studies have been conducted on the appropriate way to measure and quantify medication adherence, but none have reached a consensus that could serve as the gold standard, both in cross-sectional and longitudinal studies. [31, 32, 3... | [] |
NCT04111965 | 6.5 | Strategies to improve adherence | 6.5 Strategies to improve adherence - 1. The PI will sensitize the subject to the importance of correctly applying the PI to achieve the study objectives. - 2. Direct questioning by the IP regarding the application of the PI. - 3. Delivery of a printed calendar specifying the date of the visit and its activities. - 4. ... | [] |
NCT04111965 | 7 | Methods and procedures of the study | 7. Methods and procedures of the study | [] |
NCT04111965 | 7.1 | From the research center | 7.1 From the research center This study will be conducted at research centers previously evaluated by the sponsor. These centers will be institutions or establishments that conduct health research and comply with current regulations. The research center will be responsible for forming a multidisciplinary research team ... | [] |
NCT04111965 | 7.2 | Clinical study registration | 7.2 Clinical study registration This clinical study will be registered by the sponsor in public clinical trial registries prior to its initiation (enrollment of the first patient): the National Registry of Clinical Trials (RNEC) of the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) and on a WHO... | [] |
NCT04111965 | 7.3 | Randomization and blinding | 7.3 Randomization and blinding Subject randomization will be performed using a computerized allocation system. After signing the FCI, the patient will receive a patient number, which will be used to pseudonymize all information during collection and completely anonymize it during analysis. The generation will be carrie... | [] |
NCT04111965 | 7.3.1 | Opening of the cecum | 7.3.1 Opening of the cecum The cecum may be opened in the following cases: - 1. Presence of a serious adverse event. - 2. Safety alert for the use of the drugs under study. - 3. In the event that the sponsor determines it for any security reason or other reason that it deems appropriate. - 4. In the event that the regu... | [] |
NCT04111965 | 7.4 | Outcome variables | 7.4 Outcome variables | [] |
NCT04111965 | 7.4.1 | Primary outcome variables | 7.4.1 Primary outcome variables - OSDI Test Score (TE: Day 29) - Incidence of unexpected AEs related to the PI (TE: day 8 and 29) | [] |
NCT04111965 | 7.4.2 | Secondary outcome variables | 7.4.2 Secondary outcome variables - Changes in BCVA (TE: day 8 and 29) - Changes in TRPL with fluorescein (TE: day 8 and 29) - Corneal fluorescein staining changes (TE: day 8 and 29) - Conjunctival staining changes with lissamine green (TE: day 8 and 29) - Incidence of expected AEs (TE day 8 and 29) | [] |
NCT04111965 | 7.4.3 | Exploratory outcome variable | 7.4.3 Exploratory outcome variable - Average number of applications performed daily | [] |
NCT04111965 | 7.4.4 | Definition of variables, methods and scales to be used for measurement | 7.4.4 Definition of variables, methods and scales to be used for measurement | Variable | Guy | Unit (symbol) | Measurementmethod | Normalvalue | Evaluationtime | Statisticaltest | | |-----------------------------------------------------|------------------------|----------------------------------|----------------------... | [] |
NCT04111965 | 7.4.4.1 | OSDI Score | 7.4.4.1 OSDI Score The OSDI is a validated and reliable instrument for measuring dry eye severity. It has the psychometric properties necessary for use as an outcome variable in clinical studies. [40]It consists of a 3-question, 12-item questionnaire. Responses are based on frequency and offer 5 options, ranging from 4... | [] |
NCT04111965 | 7.4.4.2 | Adverse events | 7.4.4.2 Adverse events As defined in section [8.2,](#page-45-2) an EA It is any unfavorable medical occurrence in a subject to whom a PI is administered, regardless of the causal attribution. The management of AEs will be carried out as described in the Adverse Events section. The IP will record any AEs that the study ... | [] |
NCT04111965 | 7.4.4.3 | Best Corrected Visual Acuity | 7.4.4.3 Best Corrected Visual Acuity Visual acuity (VA) is a test of visual function. Spatial VA is the ability to distinguish separate elements of an object and identify them as a whole. It is quantified as the minimum angle of separation (located at the nodal point of the eye) between two objects that allows them to ... | [] |
NCT04111965 | 7.4.4.4 | Tear film breakup time | 7.4.4.4 Tear film breakup time One of the first aspects of the tear film to change when there is a change in the ocular surface is its stability. In general, if the corneal or conjunctival surface is damaged, it is unlikely that a stable tear film can be maintained. The most common method for assessing tear film stabil... | [] |
NCT04111965 | 7.4.4.5 | Corneal staining with fluorescein | 7.4.4.5 Corneal staining with fluorescein A drop of topical anesthetic is instilled into the conjunctival fornix. A second drop is then applied to the tip of the fluorescein strip, allowing it to sit on the strip for 5 seconds to elute the dye, shaking off the excess at the end. A small amount of contact is made betwee... | [] |
NCT04111965 | 7.4.4.6 | Conjunctival staining with lissamine green | 7.4.4.6 Conjunctival staining with lissamine green After the fluorescein examination, a drop of saline solution will be applied to the tip of the lissamine green strip, allowing it to sit on the strip for 5 seconds to elute the dye. A drop from the strip is instilled into the temporal fornix while the patient looks up,... | [] |
NCT04111965 | 7.4.4.7 | Number of applications made daily | 7.4.4.7 Number of applications made daily According to the PI dosing schedule, subjects may increase the number of daily instillations. They should not decrease the number to four per eye per day. An instillation is considered separate when there are more than 10 minutes between each instillation. Similarly, if two or ... | [] |
NCT04111965 | 7.5 | Program of visits and activities of the study | 7.5 Program of visits and activities of the study | [] |
NCT04111965 | 7.5.1 | Description of activities per visit | 7.5.1 Description of activities per visit The procedures are listed in the order in which they are suggested to be performed, trying to maintain the consistency of the evaluations and, as far as possible, from the least invasive to the most invasive. | [] |
NCT04111965 | 7.5.1.1 | Baseline Visit | 7.5.1.1 Baseline Visit - Signature of the ICF : refers to the signing of the written informed consent document. Without informed consent, none of the study procedures can be performed. - Medical record: refers to the technical, clinical, and legal document that chronologically records the patient's health conditions, m... | [] |
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