A Study Evaluating the 24-Hour Intraocular Pressure Lowering Effect of Bimatoprost SR in Patients With Open-Angle Glaucoma or Ocular Hypertension
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|ClinicalTrials.gov Identifier: NCT04285580|
Recruitment Status : Recruiting
First Posted : February 26, 2020
Last Update Posted : August 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Open-Angle Glaucoma Ocular Hypertension||Drug: Bimatoprost SR Drug: LUMIGAN||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Evaluation of the 24-Hour Intraocular Pressure(IOP)-Lowering Effect of Bimatoprost Sustained-Release(SR) in Participants With Open-Angle Glaucoma(OAG) or Ocular Hypertension(OHT)|
|Actual Study Start Date :||June 11, 2020|
|Estimated Primary Completion Date :||March 12, 2021|
|Estimated Study Completion Date :||December 11, 2021|
Experimental: Bimatoprost SR 10 μg
Participants will receive Bimatoprost SR 10 μg implant in the study eye on Day 1 and standard of care treatment in the fellow eye for the duration of the study.
Drug: Bimatoprost SR
Consists of 1 Bimatoprost SR administration in the study eye.
Participants will receive topical LUMIGAN 0.01% in the study eye once daily starting evening Dose on Day 1 and standard of care treatment in the fellow eye for the duration of the study.
Treatment with LUMIGAN 0.01% begins on Day 1. The drop will be instilled once daily in the evening to the study eye throughout the duration of the study.
- Change from Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR treated eyes [ Time Frame: 8 weeks ]IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
- Number of patients experiencing one or more treatment emergent adverse events (TEAEs) [ Time Frame: Up to 12 months ]The number of patients who experienced one or more TEAEs
- Change from Baseline in range of IOP for Bimatoprost SR-treated eyes [ Time Frame: 8 Weeks ]IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04285580
|Contact: Clinical Trial Registry Team||877-277-8566||IR-CTRegistration@allergan.com|
|United States, Alabama|
|Eye Center South||Not yet recruiting|
|Dothan, Alabama, United States, 36301|
|United States, California|
|Eye Research Foundation||Recruiting|
|Newport Beach, California, United States, 92663|
|United States, Pennsylvania|
|Scott & Christie and Associates||Recruiting|
|Cranberry Township, Pennsylvania, United States, 16066|
|Contact: Study Coordinator 724-772-5420|
|United States, Texas|
|Keystone Research LTD||Recruiting|
|Austin, Texas, United States, 78731|
|Contact: Study Coordinator 512-451-4400|
|Study Director:||Marina Bejanian||Allergan|