Efficacy and Safety of Bimatoprost Sustained-Release (SR) in Patients With Open-Angle Glaucoma or Ocular Hypertension

Allergan

Status and phase: Completed; Phase 3

Conditions: Ocular Hypertension; Glaucoma, Open-Angle

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02250651

2014-003186-24 (EudraCT Number)

192024-092

Details and patient eligibility

About

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

Enrollment: 528 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 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: Triple Blind

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528 participants in 3 patient groups

Bimatoprost SR 15 μg

Experimental group

Description:

Study Eye: bimatoprost sustained-release (SR) 15 micrograms (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: Bimatoprost SR

Other: Sham: Applicator Without Needle

Drug: Active Comparator: Timolol 0.5%

Drug: Timolol Vehicle (placebo)

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: Bimatoprost SR

Other: Sham: Applicator Without Needle

Drug: Active Comparator: Timolol 0.5%

Drug: Timolol Vehicle (placebo)

Timolol 0.5%: Comparator

Active Comparator group

Description:

Both Eyes: 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:

Other: Sham: Applicator Without Needle

Drug: Active Comparator: Timolol 0.5%