A Study Evaluating the 24-Hour Intraocular Pressure Lowering Effect of Bimatoprost SR in Patients With Open-Angle Glaucoma or Ocular Hypertension
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04285580|
Recruitment Status : Active, not recruiting
First Posted : February 26, 2020
Last Update Posted : June 29, 2021
|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 :||August 11, 2021|
|Estimated Study Completion Date :||May 15, 2022|
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
|United States, Alabama|
|Trinity Research Group /ID# 232749|
|Dothan, Alabama, United States, 36301|
|United States, California|
|Eye Research Foundation /ID# 232694|
|Newport Beach, California, United States, 92663|
|United States, Georgia|
|Coastal Research Associates /ID# 232798|
|Roswell, Georgia, United States, 30076|
|United States, North Carolina|
|James D Branch MD /ID# 232718|
|Winston-Salem, North Carolina, United States, 27101|
|United States, Pennsylvania|
|Scott and Christie and Associates /ID# 232747|
|Cranberry Township, Pennsylvania, United States, 16066|
|United States, Texas|
|Keystone Research LTD /ID# 232665|
|Austin, Texas, United States, 78731-4203|
|Study Director:||ALLERGAN INC.||Allergan|