Evaluation of the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension

Study Overview
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Brief Summary
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This study evaluates the duration of intraocular pressure (IOP)-lowering effect and safety of as needed administrations of Bimatoprost sustained release (SR) in participants with open-angle glaucoma (OAG) or ocular hypertension (OHT) who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy.

Official Title
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A Phase 3b Study to Evaluate the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension

Conditions
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Open-Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Bimatoprost (SR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Diagnosis of either Diagnosis of either open angle glaucoma (OAG) (i.e., primary OAG, pseudoexfoliation glaucoma, pigmentary glaucoma) or ocular hypertension requiring intraocular pressure-lowering treatment. Exclusion Criteria: Concurrent or anticipated enrollment in another investigational drug or device study or participation in such a study within 2 months prior to enrolling in this study. Previous administration with Bimatoprost SR in the study eye.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bimatoprost SR - Dose A<br>Study Eye: Participants will receive 1 - 3 Cycles of Bimatoprost SR administrations of Dose A Fellow Eye: The eye that does not receive Bimatoprost SR treatment will receive standard of care or up to one administration of Bimatoprost SR. | Drug: Bimatoprost (SR)<br>* Study Eye: Cycles 1 - 3 administrations through the PRN treatment period. Fellow Eye: Standard of care or Bimatoprost SR.<br>|
| Experimental: Bimatoprost SR - Dose B<br>Study Eye: Participants received 1-3 Cycles of Bimatoprost SR administrations of Dose B Fellow Eye: The eye that does not receive Bimatoprost SR treatment will receive standard of care or up to one administration of Bimatoprost SR. | Drug: Bimatoprost (SR)<br>* Study Eye: Cycles 1 - 3 administrations through the PRN treatment period. Fellow Eye: Standard of care or Bimatoprost SR.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retreatment or rescue administered for IOP | Treatment modality determined by investigator. | Up to 48 months | 
| Number of patients experiencing a treatment emergent adverse event | The number of patients who experienced one or more TEAE during the 48 month treatment period. | Baseline up to 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open-Angle Glaucoma (OAG), Ocular Hypertension (OHT), Bimatoprost