Safety and Efficacy of Bimatoprost Sustained-Release (SR) in Patients With Open-Angle Glaucoma or Ocular Hypertension
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ClinicalTrials.gov Identifier: NCT02250651 |
Recruitment Status :
Completed
First Posted : September 26, 2014
Last Update Posted : June 22, 2020
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Condition or disease | Intervention/treatment | Phase |
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Glaucoma, Open-Angle Ocular Hypertension | Drug: Bimatoprost sustained-release Other: Sham Drug: Timolol Drug: Timolol Vehicle (placebo) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 527 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | The Efficacy and Safety of Bimatoprost SR in Patients With Open-angle Glaucoma or Ocular Hypertension |
Actual Study Start Date : | December 16, 2014 |
Actual Primary Completion Date : | October 25, 2018 |
Actual Study Completion Date : | May 7, 2020 |
Arm | Intervention/treatment |
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Experimental: Bimatoprost SR Dose A
Study Eye: bimatoprost sustained-release (SR) Dose A administered on Day 1, Week 16, and Week 32; timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1, Week 16, and Week 32; timolol administered once in the morning and once in the evening for up to 20 months.
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Drug: Bimatoprost sustained-release
Bimatoprost sustained-release (SR) administered in the study eye on Day 1, Week 16, and Week 32. Other: Sham Sham administered on Day 1, Week 16, and Week 32, as per protocol. Drug: Timolol Timolol administered once in the morning and once in the evening for up to 20 months, as per protocol.
Other Name: TIMOPTIC® Drug: Timolol Vehicle (placebo) Timolol vehicle administered once in the morning and once in the evening for up to 20 months, as per protocol. |
Experimental: Bimatoprost SR Dose B
Study Eye: bimatoprost SR Dose B administered on Day 1, Week 16, and Week 32; timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1, Week 16, and Week 32; timolol administered once in the morning and once in the evening for up to 20 months.
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Drug: Bimatoprost sustained-release
Bimatoprost sustained-release (SR) administered in the study eye on Day 1, Week 16, and Week 32. Other: Sham Sham administered on Day 1, Week 16, and Week 32, as per protocol. Drug: Timolol Timolol administered once in the morning and once in the evening for up to 20 months, as per protocol.
Other Name: TIMOPTIC® Drug: Timolol Vehicle (placebo) Timolol vehicle administered once in the morning and once in the evening for up to 20 months, as per protocol. |
Sham Comparator: Sham
Both Eyes: sham administered on Day 1, Week 16, and Week 32; timolol administered once in the morning and once in the evening for up to 20 months.
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Other: Sham
Sham administered on Day 1, Week 16, and Week 32, as per protocol. Drug: Timolol Timolol administered once in the morning and once in the evening for up to 20 months, as per protocol.
Other Name: TIMOPTIC® |
- Change from Baseline in Intraocular Pressure (IOP) in the Study Eye [ Time Frame: Baseline, Week 12 ]
- IOP in the Study Eye [ Time Frame: Week 2 ]
- IOP in the Study Eye [ Time Frame: Week 6 ]
- IOP in the Study Eye [ Time Frame: Week 12 ]
- Change from Baseline in IOP in the Study Eye [ Time Frame: Baseline, Week 2, Week 6 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of either open-angle glaucoma or ocular hypertension in each eye and both eyes require IOP-lowering treatment.
Exclusion Criteria:
- Previous enrollment in another Allergan Bimatoprost SR Study
- Eye surgery (including cataract surgery) and/or any eye laser surgery within the past 6 months in the study eye
- Anticipated need for laser eye surgery within the first 52 weeks of the study duration
- History of glaucoma surgery

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): NCT02250651

Study Director: | Margot Goodkin | Allergan |
Responsible Party: | Allergan |
ClinicalTrials.gov Identifier: | NCT02250651 |
Other Study ID Numbers: |
192024-092 2014-003186-24 ( EudraCT Number ) |
First Posted: | September 26, 2014 Key Record Dates |
Last Update Posted: | June 22, 2020 |
Last Verified: | June 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Glaucoma Glaucoma, Open-Angle Ocular Hypertension Hypertension Vascular Diseases Cardiovascular Diseases Eye Diseases Timolol Bimatoprost |
Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Arrhythmia Agents Antihypertensive Agents |