AN EXTENSION TRIAL TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF BIMATOPROST SR IN PATIENTS WITH OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSIO

AbbVie Inc o tambien conocido como AbbVie,0 个研究点目标入组 0 人开始时间: 2020年2月10日最近更新: 2024年8月20日

研究概览

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•Patients are eligible to be included in this study only if all of the following criteria apply:
•1. Written informed consent and authorization for use and release of personal health information are obtained in accordance with the relevant country and local privacy requirements, where applicable (eg, Written Authorization for Use and Release of Health and Research Study Information [US sites] and written Data Protection consent [EU) sites])
•2. Patient has the ability to understand and willingness to follow study instructions and is likely to complete all required visits and procedures
•3. Negative pregnancy test at Screening/Enrollment for females of childbearing potential (as defined in Appendix 6)
•4. Patients who completed 1 of the 4 Bimatoprost SR Phase 3 studies (192024-091, -092, -093, or -095) and who were:
•a. Not rescued (refers to having received nonstudy IOP-lowering medication[s] or procedure[s] or both, hereafter) in the eye that received Bimatoprost SR, OR
•b. Rescued in the eye that received Bimatoprost SR and require additional safety follow-up for that eye based on the investigator’s discretion, OR
•c. Rescued in the eye that received Bimatoprost SR and require no additional safety follow-up but have clinically significant implant remnants remaining based on the investigator’s judgment

•Patients are excluded from the study if any of the following criteria apply:
•1. Patients who were randomized to receive timolol eye drops in the study eye (control group) during the Phase 3 Bimatoprost Studies 192024-091 and -092
•2. Female patients who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception during the study (see Appendix 6)
•3. Concurrent or anticipated enrollment in another investigational drug or device study during the present study
•4. Any condition which would preclude the patient’s ability to comply with study requirements, including completion of the study
•5. Patients who have a condition or are in a situation which, in the investigator’s opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient’s participation in the study

发起方

AbbVie Inc o tambien conocido como AbbVie,