An Extension Trial to Evaluate the Long-term Safety and Efficacy of Bimatoprost SR inPatients with Open Angle Glaucoma or Ocular Hypertension - Long-term Safety and Efficacy of Bimatoprost SR

AbbVie *Deutschland GmbH & Co. KG0 个研究点目标入组 600 人开始时间: 2019年7月23日最近更新: 2022年3月28日

适应症

试验速览

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•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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 400
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 200

•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

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