Efficacy and Safety Study of Bimatoprost Sustained-Release (SR) in Participants With Open-angle Glaucoma or Ocular Hypertension

Allergan

Status and phase: Completed; Phase 3

Conditions: Ocular Hypertension; Glaucoma, Open-Angle

Treatments: Drug: Active Comparator: Timolol 0.5%; Drug: Bimatoprost SR; Drug: Timolol Vehicle (placebo); Other: Sham: Applicator Without Needle

Study type: Interventional

Funder types: Industry

Identifiers

NCT02247804

2014-003037-26 (EudraCT Number)

192024-091

Details and patient eligibility

About

This study will evaluate the efficacy and safety of bimatoprost SR in participants with open-angle glaucoma or ocular hypertension. The study includes a 12-month treatment period with an 8-month extended follow-up.

Enrollment: 594 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 in either eye within the first 52 weeks of the study duration
• History of glaucoma surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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594 participants in 3 patient groups

Bimatoprost SR 15 μg

Experimental group

Description:

Study Eye: bimatoprost sustained release (SR) 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); 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 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.

Treatment:

Drug: Active Comparator: Timolol 0.5%

Drug: Timolol Vehicle (placebo)

Other: Sham: Applicator Without Needle

Drug: Bimatoprost SR

Bimatoprost SR 10 μg

Experimental group

Description:

Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); 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 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.

Treatment:

Drug: Active Comparator: Timolol 0.5%

Drug: Timolol Vehicle (placebo)

Other: Sham: Applicator Without Needle

Drug: Bimatoprost SR

Timolol 0.5%

Active Comparator group

Description:

Study Eye and Non-Study Eye: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.

Treatment:

Drug: Active Comparator: Timolol 0.5%

Other: Sham: Applicator Without Needle