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protocol_id stringclasses 263 values	section_number stringlengths 1 12	title stringlengths 1 1.88k	content stringlengths 0 866k	merged_titles listlengths 0 491
NCT04074330	8.6	Dose Management and Modification Guidelines	8.6 Dose Management and Modification Guidelines Patients will be evaluated according to the SOE (Appendix A) for possible toxicities. Toxicities are to be assessed according to the NCI CTCAE Version 5.0; except CRS which will be graded according to ASTCT Consensus Grading for CRS (Lee et al. 2019).The causal relationsh...	[]
NCT04074330	8.6.1	Intrapatient Dose Escalation	8.6.1 Intrapatient Dose Escalation Patients who have tolerated treatment at the initially assigned dose may have their doses of TAK-981 increased in subsequent cycles of treatment only if all patients in the next dose level cohort have completed assessment for Cycle 1 and a decision has been made that this dose level d...	[]
NCT04074330	8.6.2	Criteria for Beginning or Delaying a Subsequent Treatment Cycle	8.6.2 Criteria for Beginning or Delaying a Subsequent Treatment Cycle A treatment cycle in this study is 21 days. For a new cycle of treatment to begin, the patient must meet the following criteria: - ANC ≥1.0 × 109 /L. - Platelet count ≥75.0 × 109 /L (platelet count ≥50.0 × 109 /L if no change on the baseline platelet...	[]
NCT04074330	8.6.3	Criteria for Dose Interruption or Dose Reduction	8.6.3 Criteria for Dose Interruption or Dose Reduction All toxicities that occur during the study will be actively managed following the standard of care unless otherwise specified in the protocol. Patients experiencing AEs attributed to TAK-981, rituximab, or the combination may continue study treatment with the same ...	[]
NCT04074330	8.6.3.1	TAK-981	8.6.3.1 TAK-981 Dosing of TAK-981 should be interrupted during a treatment cycle or reduced according to the dose modification recommendations listed in Table 8.a for nonhematologic toxicity and Table 8.b for hematologic toxicities. When the dose of TAK-981 is withheld based on the listed criteria, clinical and laborat...	[]
NCT04074330	8.6.3.2	Rituximab	8.6.3.2 Rituximab In this study the dose of rituximab cannot be modified. Depending on the toxicity observed the infusion of rituximab can be interrupted (in case of IRR, for example), delayed, or discontinued. If hypersensitivity or infusion-related events develop, the infusion should be temporarily slowed or interrup...	[]
NCT04074330	8.6.3.3	COVID-19 Infection	8.6.3.3 COVID-19 Infection If a patient is diagnosed with COVID-19 infection while on study, study treatment must be withheld until resolution of the infection. A patient may restart study treatment if the following criteria are met; otherwise the patient must discontinue treatment: - The infection must have resolved w...	[]
NCT04074330	8.6.4	Criteria for Discontinuation of Study Treatment Due to AEs	8.6.4 Criteria for Discontinuation of Study Treatment Due to AEs Treatment with study drug must be discontinued for any of the following reasons: - Occurrence of a DLT in dose escalation during the first cycle (exceptions to this criterion may be made after discussion and agreement between the investigator and the spon...	[]
NCT04074330	8.9	Precautions and Restrictions	8.9 Precautions and Restrictions Precautions and requirements for a safe administration of TAK-981 and/or rituximab are detailed in Section 8.1. It is not known what effects TAK-981 or rituximab has on human pregnancy or development of the embryo or fetus; therefore, female patients participating in this study should a...	[]
NCT04074330	8.10	Management of Clinical Events	8.10 Management of Clinical Events Therapies that are required to manage AEs and control cancer symptoms are allowed based on standard clinical practice, unless specifically excluded. Supportive care agents, such as erythropoietin, granulocyte colony-stimulating factor, blood products (RBC and platelet transfusions), a...	[]
NCT04074330	8.10.1	Nausea or Vomiting	8.10.1 Nausea or Vomiting This study will not initially employ prophylactic antiemetics before the first dose of the study drug during dose escalation. However, a patient who develops nausea or vomiting will be actively managed by employing optimal antiemetic treatment based on local standard practice. Additionally, an...	[]
NCT04074330	8.10.2	Diarrhea	8.10.2 Diarrhea This study will not initially employ prophylactic antidiarrheals; however, there is no prohibition against their use in the management of a patient who develops diarrhea. Patients will be instructed to take antidiarrheal medication(s) (ie, loperamide) at the physician's discretion until they are diarrhe...	[]
NCT04074330	8.10.3	Anemia, Thrombocytopenia, or Neutropenia	8.10.3 Anemia, Thrombocytopenia, or Neutropenia Please refer to Table 8.b for dose delay and reduction recommendations for hematologic toxicities. TAK-981 should be held if a significant treatment-emergent cytopenia or bleeding is suspected to be related to, or can be worsened by, study treatment. Precautionary measure...	[]
NCT04074330	8.10.4	Infusion Site Care	8.10.4 Infusion Site Care Skin lesions, which may include inflammation or necrosis, represent a potential risk of TAK-981 and were observed at the injection site in rats. Local institutional guidelines must be applied to stress proper administration and prevention of accidental extravasation of TAK-981. Usage of IV por...	[]
NCT04074330	8.10.5	Lymphopenia and Opportunistic Infection Prophylaxis	8.10.5 Lymphopenia and Opportunistic Infection Prophylaxis Because lymphopenia is one of the most common AEs associated with the use of rituximab and is also an expected TAK-981–related AE, patients may be at an increased risk of opportunistic pathogens. Follow-up with standard hemograms and serial immunophenotyping wi...	[]
NCT04074330	8.10.6	IRRs	8.10.6 IRRs Rituximab can cause severe, including fatal, infusion reactions. Severe reactions typically occurred during the first infusion with time to onset of 30 to 120 minutes. Premedication with an antihistamine and acetaminophen is required before rituximab dosing, in accordance with local best practices. Should i...	[]
NCT04074330	8.10.7	CRS	8.10.7 CRS CRS should be diagnosed and managed following institutional guidelines and graded following ASTCT Consensus Grading for CRS (Lee et al. 2019). Recommendations for management of CRS are shown in Table 8.d and can be implemented at the investigator's discretion. Please refer to Table 8.c for dose modifications...	[]
NCT04074330	8.10.8	TLS	8.10.8 TLS Rituximab rapidly decreases the number of benign and malignant CD20+ cells, which can result in TLS (as defined in Appendix L). TLS has been reported to occur within 12 to 24 hours after the first rituximab infusion in patients with NHL. The risk of TLS is a continuum based on multiple factors, including com...	[ "Laboratory Assessments:" ]
NCT04074330	8.11	Blinding and Unblinding	8.11 Blinding and Unblinding This is an open-label study. For non-commercial use only Commercially available IV formulation of rituximab background therapy will be used. The Sponsor will provide commercial supplies of rituximab for IV administration, labeled appropriately for investigational use as per the regulations ...	[]
NCT04074330	8.14	Packaging and Labeling	8.14 Packaging and Labeling All label information will fulfill requirements specified by local governing regulations. Additional details are provided in the pharmacy manual.	[]
NCT04074330	8.15	Storage, Handling, and Accountability	8.15 Storage, Handling, and Accountability TAK-981 Complete receipt, inventory, accountability, reconciliation, and destruction records will be maintained for all used and unused study drug vials. A drug dispensing log, including records of drug received from the sponsor and drug dispensed to patients will be provided...	[ "TAK-981", "Rituximab" ]
NCT04074330	8.16	Other Protocol-Specified Materials	8.16 Other Protocol-Specified Materials Information on supplies required by the site for drug administration is provided in the pharmacy manual. Clinical supplies other than study drug to be provided by the sponsor or designee are specified in the study manual.	[]
NCT04074330	9.0	STUDY CONDUCT	9.0 STUDY CONDUCT This study will be conducted in compliance with the protocol, GCP, applicable regulatory requirements, and ICH guidelines.	[]
NCT04074330	9.1	Study Personnel and Organizations	9.1 Study Personnel and Organizations The contact information for the project clinician for this study, the central laboratory and any additional clinical laboratories, the coordinating investigator, and other vendors such as the interactive response technology provider, may be found in the study manual. A full list of...	[]
NCT04074330	9.2	Arrangements for Recruitment of Patients	9.2 Arrangements for Recruitment of Patients Recruitment and enrollment strategies for this study may include recruitment from the investigator's local practice or referrals from other physicians. If advertisements become part of the recruitment strategy, they will be reviewed by the IRB. Prisoners (or other population...	[]
NCT04074330	9.3	Treatment Group Assignments	9.3 Treatment Group Assignments This is not a randomized study. Patient assignment to a specific schedule will be decided jointly by the investigator and sponsor with the aim of maximizing enrollment efficiency in the study. Details can be found in the cohort management plan.	[]
NCT04074330	9.4	Study Procedures	9.4 Study Procedures Patients will be evaluated at scheduled visits over the following study periods: Screening, treatment, EOT, follow-up, and end of study. Evaluations during the screening period are to be conducted within 28 days before administration of the first dose of the study drug. Procedures conducted during ...	[]
NCT04074330	9.4.1	Informed Consent	9.4.1 Informed Consent Each patient must provide written informed consent before any study-required procedures are conducted, unless those procedures are performed as part of the patient's standard care.	[]
NCT04074330	9.4.2	Patient Demographics	9.4.2 Patient Demographics The date of birth, race, ethnicity, and sex of the patient are to be recorded during screening.	[]
NCT04074330	9.4.3	Medical History	9.4.3 Medical History During the screening period, a complete medical history will be compiled for each patient. The history will emphasize the background and progress of the patient's malignancy and include a description of prior therapies for it and the best response achieved by each one. In addition, concomitant med...	[]
NCT04074330	9.4.4	Physical Examination	9.4.4 Physical Examination A physical examination will be completed per standard of care at the times specified in the SOE (Appendix A). Any clinically relevant findings are to be documented.	[]
NCT04074330	9.4.5	Patient Height and Weight	9.4.5 Patient Height and Weight Height will be measured only during screening. Body weight should be recorded as specified in the SOE (Appendix A). For non-commercial use only	[]
NCT04074330	9.4.6	ECOG Performance Status	9.4.6 ECOG Performance Status Performance status is to be assessed using the ECOG scale (see Appendix D for a description of the scale) at the times specified in the SOE (Appendix A).	[]
NCT04074330	9.4.7	Vital Signs	9.4.7 Vital Signs Vital signs (blood pressure, heart rate, and temperature) will be monitored as specified in the SOE (Appendix A).	[]
NCT04074330	9.4.8	Viral Serologies	9.4.8 Viral Serologies Serological tests for hepatitis B (hepatitis B surface antigen [HBsAg] and IgG anti-hepatitis B core antibody), hepatitis C virus ([HCV]-antibody, also HCV-RNA by polymerase chain reaction if the patient is HCV-antibody positive), and HIV at screening period. For patients who show evidence of pri...	[]
NCT04074330	9.4.9	Pregnancy Test	9.4.9 Pregnancy Test A serum/urine pregnancy test will be obtained for women of childbearing potential at screening, C1D1, on Day 1 of each cycle, and at the EOT. The screening results must be available and negative before enrollment. For women of childbearing potential, if menstrual period is delayed during the study,...	[]
NCT04074330	9.4.14.2	Immunosafety Markers	9.4.14.2 Immunosafety Markers Blood samples for the analysis of autoimmune endocrinopathies as shown in Table 9.c will be obtained as specified in the SOE (Appendix A). They will be performed locally only. Results may be evaluated after dosing. Table 9.c Immunosafety Determinations in Serum \| \| onlySerum Chemistry \| \|-...	[]
NCT04074330	9.4.14.3	Complement System Proteins	9.4.14.3 Complement System Proteins	[]
NCT04074330	9.4.15	Disease Assessment	9.4.15 Disease Assessment	[]
NCT04074330	9.4.15.1	Imaging	9.4.15.1 Imaging Appropriate cancer staging assessments should be performed (eg, MRI, FDG-PET-CT). Imaging assessments should be conducted according to Lugano Classification for staging and response assessment (Cheson et al. 2014). A baseline contrast-enhanced CT or MRI scan of the chest, abdomen, and pelvis in additio...	[]
NCT04074330	9.7	Discontinuation of Treatment With Study Drug and Patient Replacement	9.7 Discontinuation of Treatment With Study Drug and Patient Replacement Patients will be informed that they have the right to discontinue study treatment at any time for any reason, without prejudice to their medical care. Treatment with study drug must be discontinued for any of the following reasons: - Pregnancy. - ...	[]
NCT04074330	9.8	Study Compliance	9.8 Study Compliance Study drug will be administered or dispensed only to eligible patients under the supervision of the investigator or identified subinvestigator(s). The appropriate study personnel will maintain records of study drug receipt and dispensing.	[]
NCT04074330	9.9	Posttreatment Follow-up Assessments	9.9 Posttreatment Follow-up Assessments Patients who stop treatment for any reason other than PD will continue to have PFS follow-up visits. The PFS follow-up visit should be conducted at the site every 12 weeks ±1 week from the last dose of study drug until the occurrence of PD, loss to follow-up, consent withdrawal, ...	[]
NCT04074330	9.10	Early Study Termination	9.10 Early Study Termination The study may be terminated early by the sponsor at any time for reasons that may include a potential health hazard to patients, poor enrollment of patients (thus, making completion of the trial in an acceptable timeframe unlikely), or modification or discontinuation of study drug developme...	[]
NCT04074330	10.0	ADVERSE EVENTS	10.0 ADVERSE EVENTS	[]
NCT04074330	10.1	Definitions	10.1 Definitions	[]
NCT04074330	10.1.1	Pretreatment Event Definition	10.1.1 Pretreatment Event Definition A pretreatment event is any untoward medical occurrence in a patient or subject who has signed informed consent to participate in a study but before administration of any study medication; it does not necessarily have to have a causal relationship with study participation.	[]
NCT04074330	10.1.2	AE Definition	10.1.2 AE Definition AE means any untoward medical occurrence in a patient or subject administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory f...	[]
NCT04074330	10.1.3	SAE Definition	10.1.3 SAE Definition SAE means any untoward medical occurrence that at any dose: - Results in death. - Is life-threatening (refers to an AE in which the patient was at risk of death at the time of the event. It does not refer to an event which hypothetically might have caused death if it were more severe). - Requires ...	[]
NCT04074330	10.2	Procedures for Recording and Reporting AEs and SAEs	10.2 Procedures for Recording and Reporting AEs and SAEs All AEs spontaneously reported by the patient or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures will be recorded on the appropriate page of the eCRF (see Section 10.3 for the p...	[]
NCT04074330	10.3	Monitoring of AEs and Period of Observation	10.3 Monitoring of AEs and Period of Observation AEs, both nonserious and serious, will be monitored throughout the study as follows: - AEs will be reported from the signing of informed consent through 30 days after administration of the last dose of study drug and recorded in the eCRFs. AEs ongoing at EOT should be mo...	[]
NCT04074330	10.4	Procedures for Reporting Drug Exposure During Pregnancy and Birth Events	10.4 Procedures for Reporting Drug Exposure During Pregnancy and Birth Events If a woman becomes pregnant or suspects that she is pregnant while participating in this study, she must inform the investigator immediately and permanently discontinue study drug. The sponsor must also be contacted immediately by sending a c...	[]
NCT04074330	10.5	Procedures for Reporting Product Complaints or Medication Errors (Including Overdose)	10.5 Procedures for Reporting Product Complaints or Medication Errors (Including Overdose) A product complaint is a verbal, written, or electronic expression that implies dissatisfaction regarding the identity, strength, purity, quality, or stability of a drug product. Individuals who identify a potential product compl...	[]
NCT04074330	10.6	Safety Reporting to Investigators, IRBs or IECs, and Regulatory Authorities	10.6 Safety Reporting to Investigators, IRBs or IECs, and Regulatory Authorities The sponsor will be responsible for reporting all suspected unexpected serious adverse reactions and any other applicable SAEs to regulatory authorities, including investigators and IRBs, as applicable, in accordance with national regulati...	[]
NCT04074330	11.0	STUDY-SPECIFIC COMMITTEES	11.0 STUDY-SPECIFIC COMMITTEES	[]
NCT04074330	11.1	SMC	11.1 SMC During Phase 1, an SMC composed of the principal investigators and sponsor clinician will regularly review safety data to ensure patient safety throughout the study and make decisions on dose escalation as defined in the SMC charter.	[]
NCT04074330	11.2	IDMC	11.2 IDMC During Phase 2, an IDMC will be established to monitor safety and assess benefit/risk throughout the conduct of the Phase 2 portion of the study. The IDMC will consist of 3 to 5 members not associated with the conduct of the study and/or the sponsor with the exception of the compensation to IDMC members relat...	[]
NCT04074330	11.3	Independent Review Committee	11.3 Independent Review Committee All imaging performed to assess response to treatment will be submitted to a central core imaging repository. An independent review committee (IRC) will be established to independently review efficacy imaging endpoints once any cohort in Phase 2 meets the efficacy threshold in Stage 1 ...	[]
NCT04074330	12.0	DATA HANDLING AND RECORDKEEPING	12.0 DATA HANDLING AND RECORDKEEPING The full details of procedures for data handling will be documented in the data management plan. If selected for coding, AEs, medical history, and concurrent conditions will be coded using the Medical Dictionary for Regulatory Activities. Drugs will be coded using the World Health O...	[]
NCT04074330	12.1	eCRFs	12.1 eCRFs Completed eCRFs are required for each subject who signs an ICF. The sponsor or its designee will supply investigative sites with access to eCRFs and will make arrangements to train appropriate site staff in the use of the eCRF. These forms are used to transmit the information collected in the performance of ...	[]
NCT04074330	12.2	Record Retention	12.2 Record Retention The investigator agrees to keep the records stipulated in Section 12.1 and those documents that include (but are not limited to) the study-specific documents, the identification log of all participating subjects, medical records, temporary media such as thermal-sensitive paper, source worksheets, ...	[]
NCT04074330	13.1.2	Analysis of Demographics and Other Baseline Characteristics	13.1.2 Analysis of Demographics and Other Baseline Characteristics Patient demographic and baseline characteristics will be summarized descriptively. Variables to be analyzed include gender, age, race, medical history, prior medications/therapies, ECG findings, and other parameters as appropriate. For continuous variab...	[]
NCT04074330	13.1.3	Efficacy Analysis	13.1.3 Efficacy Analysis	[]
NCT04074330	13.1.3.1	Primary Efficacy Analysis	13.1.3.1 Primary Efficacy Analysis Phase 1: Efficacy is not the primary objective for this study in the Phase 1 portion. The efficacy analysis will mainly focus on the Phase 2 portion of this study. In the Phase 1 portion of this study, efficacy parameters such as ORR, DOR, and PFS may be summarized as appropriate. Di...	[ "Phase 1:", "Phase 2:" ]
NCT04074330	13.1.3.2	Secondary Efficacy Analysis	13.1.3.2 Secondary Efficacy Analysis Secondary efficacy endpoints include DCR, DOR, TTP, and PFS. DCR is defined as the proportion of patients who achieve CR, PR, or SD (determined by the investigator) during the study. DOR is the time from the date of first documentation of a PR or better to the date of first document...	[]
NCT04074330	13.1.4	PK Analysis	13.1.4 PK Analysis The PK of TAK-981 will be characterized in this study (ie, rituximab PK will not be characterized). PK parameters for TAK-981 will be estimated using noncompartmental methods with Phoenix WinNonlin software. The PK parameters will be estimated from the concentration-time profiles for the PK populatio...	[]
NCT04074330	13.1.5	Pharmacodynamic Analysis	13.1.5 Pharmacodynamic Analysis The analysis of blood and skin biomarker profiles for each dose and timepoint tested will be tabulated. When possible, the dynamic range for each biomarker and fold change will be determined to better understand TAK-981 biological activity range and duration of pharmacodynamic effect, an...	[]
NCT04074330	13.2	Interim Analysis and Criteria for Early Termination	13.2 Interim Analysis and Criteria for Early Termination In Phase 1, investigators and sponsor representatives will review accruing data to determine dose escalation and number of patients per cohort in the dose-escalation phase (see Section 8.5). During the Phase 2 part of the study, interim analysis for futility will...	[]
NCT04074330	14.3	Quality Assurance Audits and Regulatory Agency Inspections	14.3 Quality Assurance Audits and Regulatory Agency Inspections The study site also may be subject to quality assurance audits by the sponsor or designees. In this circumstance, the sponsor-designated auditor will contact the site in advance to arrange an auditing visit. The auditor may ask to visit the facilities wher...	[]
NCT04074330	15.0	ETHICAL ASPECTS OF THE STUDY	15.0 ETHICAL ASPECTS OF THE STUDY This study will be conducted with the highest respect for the individual participants (ie, subjects) according to the protocol, the ethical principles that have their origin in the Declaration of Helsinki, and the ICH Harmonised Tripartite Guideline for GCP. Each investigator will cond...	[]
NCT04074330	15.1	IRB Approval	15.1 IRB Approval IRBs and IECs must be constituted according to the applicable state and federal/local requirements of each participating region. The sponsor or designee will require documentation noting all names and titles of members who make up the respective IRB or IEC. If any member of the IRB or IEC has direct p...	[]
NCT04074330	15.2	Patient Information, Informed Consent, and Patient Authorization	15.2 Patient Information, Informed Consent, and Patient Authorization Written consent documents will embody the elements of informed consent as described in the Declaration of Helsinki and the ICH Guidelines for GCP and will be in accordance with all applicable laws and regulations. The ICF, subject authorization form ...	[]
NCT04074330	15.3	Patient Confidentiality	15.3 Patient Confidentiality The sponsor and designees affirm and uphold the principle of the subject's right to protection against invasion of privacy. Throughout this study, a subject's source data will be linked to the sponsor's clinical study database or documentation only via a unique identification number. As per...	[]
NCT04074330	15.4	Publication, Disclosure, and Clinical Trial Registration Policy	15.4 Publication, Disclosure, and Clinical Trial Registration Policy	[]
NCT04074330	15.4.1	Publication	15.4.1 Publication The investigator is obliged to provide the sponsor with complete test results and all data derived by the investigator from the study. During and after the study, only the sponsor may make study information available to other study investigators or to regulatory agencies, except as required by law or...	[]
NCT04074330	15.4.2	Clinical Trial Registration	15.4.2 Clinical Trial Registration To ensure that information on clinical trials reaches the public in a timely manner and to comply with applicable laws, regulations, and guidance, Takeda will, at a minimum, register interventional clinical trials it sponsors anywhere in the world on ClinicalTrials.gov or other public...	[]
NCT04074330	15.4.3	Clinical Trial Results Disclosure	15.4.3 Clinical Trial Results Disclosure Takeda will post the results of clinical trials on ClinicalTrials.gov, and other publicly accessible websites (including the Takeda corporate site) and registries, as required by Takeda policy/standards, applicable laws, and/or regulations. Data Sharing The sponsor is committed...	[ "Data Sharing" ]
NCT04074330	15.5	Insurance and Compensation for Injury	15.5 Insurance and Compensation for Injury Each subject in the study must be insured in accordance with the regulations applicable to the site where the subject is participating. If a local underwriter is required, then the sponsor or sponsor's designee will obtain clinical study insurance against the risk of injury to...	[]
NCT04074330	16.0	REFERENCES	16.0 REFERENCES - Adams, S. 2009. Toll-like receptor agonists in cancer therapy. Immunotherapy, 1(6), 949-64. - Armand, P., Rodig, S., Melnichenko, V., Thieblemont, C., Bouabdallah, K., Tumyan, G., et al. 2018. Pembrolizumab in patients with relapsed or refractory primary mediastinal large B-Cell lymphoma (PMBCL): data...	[ "Appendix A Schedule of Events", "Appendix B Responsibilities of the Investigator", "Appendix C Investigator Consent to Use of Personal Information", "Appendix D ECOG Scale for Performance Status", "Appendix E Drugs That Interact With the CYP3A Family of CYPs", "Drugs Inducing or Inhibiting CYP3A Metaboli...
NCT04085328	1	GLOSSARY OF TERMS	1 GLOSSARY OF TERMS \| Names of test product(s) \| Throughout this document, test product(s) will be referred toassoft contact lensesorcontact lenses \| \|--------------------------\|----------------------------------------------------------------------------------------------------------------------------------------------...	[]
NCT04085328	2	LIST OF ACRONYMS AND ABBREVIATIONS	2 LIST OF ACRONYMS AND ABBREVIATIONS Table 2–1 List of Acronyms and Abbreviations Used in This Protocol \| Abbreviation \| Definition \| \|---------------------------\|-----------------------------------------------------------\| \| ADE \| Adverse device effect \| \| AE \| Adverse event \| \| Apps \| Applications (ie, smartphone sof...	[]
NCT04085328	3	PROTOCOL SUMMARY	3 PROTOCOL SUMMARY \| double-masked, parallel-group, extended wear clinical study. \| \| \|---------------------------------------------------------------------------------------\|----------------\| \| This clinical trial will engage approximately 45 clinic sites to enroll approximately \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| - \| \| \| S...	[]
NCT04085328	4	PROTOCOL AMENDMENTS	4 PROTOCOL AMENDMENTS Modification of the protocol is prohibited without prior written agreement in the form of a protocol amendment. All amendments must be created by the Study Sponsor and must be approved by the IRB/IEC and global and regional Health Authorities, as applicable, prior to implementation except when req...	[]
NCT04085328	5	INTRODUCTION	5 INTRODUCTION	[]
NCT04085328	5.1	Rationale and Background	5.1 Rationale and Background Extended wear contact lenses have been marketed and tested in the United States and Europe since the 1970s. Extended wear contact lenses offer around the clock vision correction to patients without the inconvenience of removal for daily cleaning and disinfection. For successful overnight le...	[]
NCT04085328	5.2	Purpose of the Study	5.2 Purpose of the Study extended wear soft contact lenses were considered. The purpose of this clinical trial is to evaluate the safety and performance of thecontact lens compared to the commercially available Biofinity contact lens, by assessing ocular serious and significant non-serious ADEs as the primary safety va...	[]
NCT04085328	5.3	Risks and Benefits	5.3 Risks and Benefits Contact lenses may offer improved peripheral vision and the convenience of not wearing spectacles. Biofinity contact lenses are approved for extended wear for up to 6 nights/7 days of continuous wear. Further details on any known potential risks and benefits can be found in the package insert. Ma...	[]
NCT04085328	6	STUDY OBJECTIVES	6 STUDY OBJECTIVES	[]
NCT04085328	6.1	Primary Objective(s)	6.1 Primary Objective(s) Table 6–1 Primary Objective(s) \| Objective(s) \| Endpoint(s) \| \|-----------------------------------------------------------------------------------------------------------------------\|-----------------------------------------------------------------------\| \| Demonstrate safety and effectiveness ...	[]
NCT04085328	6.2	Secondary Objective(s)	6.2 Secondary Objective(s) Not Applicable	[]
NCT04085328	6.3	Exploratory Objective(s)	6.3 Exploratory Objective(s) Not Applicable	[]
NCT04085328	6.4	Other Safety Objective(s)	6.4 Other Safety Objective(s) Table 6–2 Other Safety Objective(s) \| Objective(s) \| Endpoint(s) \| \|-----------------------------------------------\|------------------------\| \| Duty of care and evaluation of safety profile \| AEs \| \| of the investigational products. \| Device deficiencies \| \| \| Biomicroscopy findings \|	[]
NCT04085328	7	INVESTIGATIONAL PLAN	7 INVESTIGATIONAL PLAN	[]
NCT04085328	7.1	Study Design	7.1 Study Design This will be a prospective, randomized, controlled, double-masked, parallel-group, extended wear clinical study. This clinical trial will engage approximately 45 clinic sites to enroll approximately 812 subjects Document: Version: Page 41 of 78 Status: Effective TDOC-0055758 5.0; Most-Recent; Effective...	[]
NCT04085328	7.2	Rationale for Study Design	7.2 Rationale for Study Design In this clinical trial, the safety and performance of the investigational contact lens will be compared to the commercially available Biofinity contact lens in a double-masked, parallel-group design with approximately 12 months of exposure. The study is designed primarily following the re...	[]
NCT04085328	7.3	Rationale for Duration of Treatment/Follow-Up	7.3 Rationale for Duration of Treatment/Follow-Up The duration of exposure and follow-up duration are in compliance with the recommended guidance from ISO 11980:2012. Document: TDOC-0055758 Version: 5-0; Most-Recent; Effective; CURRENT Status: Effective Page 43 of 78	[]
NCT04085328	7.4	Rationale for Choice of Control Product	7.4 Rationale for Choice of Control Product Biofinity contact lens was chosen as the control product because this lens is a proper predicate device to compare to- contact lens with regard to effectiveness and safety. Both- contact lens and Biofinity contact lens are frequent replacement SiHy lenses and are to be prescr...	[]
NCT04085328	7.5	Data Monitoring Committee	7.5 Data Monitoring Committee Not Applicable	[]
NCT04085328	8	STUDY POPULATION	8 STUDY POPULATION The study population consists of adult male or female subjects (aged 18 or over), with non-diseased eyes, who require optical correction for refractive ametropia. The aim is to enroll approximately 812 subjects in approximately 45 US sites, with approximately 18-20 subjects per site. Estimated time n...	[]
NCT04085328	8.1	Inclusion Criteria	8.1 Inclusion Criteria Written informed consent must be obtained before any study specific assessment is performed. Upon signing informed consent, the subject will be considered enrolled in the study. Subjects eligible for inclusion in this study must fulfill all of the following criteria: \| 1. \| Subject must be at lea...	[]

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