NCT02250651

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

The Efficacy and Safety of Bimatoprost SR in Patients With Open-angle Glaucoma or Ocular Hypertension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 528 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Glaucoma, Open-Angle
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	Bimatoprost SR	Bimatoprost SR administered in the study eye on Day 1, Week 16, and Week 32.
OTHER	Sham: Applicator Without Needle	Sham administered on Day 1, Week 16, and Week 32.
DRUG	Active Comparator: Timolol 0.5%	Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
DRUG	Timolol Vehicle (placebo)	Timolol vehicle administered once in the morning and once in the evening for up to 20 months.

Timeline

• Start date: 2014-12-15
• Primary completion: 2018-10-25
• Completion: 2020-07-22
• First posted: 2014-09-26
• Last updated: 2021-07-28
• Results posted: 2021-07-28

Locations

113 sites across 15 countries: United States, Argentina, Canada, Colombia, Czechia, Egypt, Germany, Italy, Malaysia, New Zealand, Singapore, South Africa, South Korea, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study