Safety and Efficacy Study of Bimatoprost in Ethnically Japanese Patients With Open-Angle Glaucoma or Ocular Hypertension

Phase 2

Completed

• Conditions: Glaucoma; Ocular Hypertension
• Interventions: Drug: Bimatoprost 0.01% Ophthalmic Solution; Drug: Bimatoprost 0.03% Ophthalmic Solution; Drug: Bimatoprost Vehicle Ophthalmic Solution

• Registration Number: NCT00651859
• Lead Sponsor: Allergan

Brief Summary

This study evaluates the safety and efficacy of once-daily bimatoprost 0.03% and 0.01% ophthalmic solutions compared with once-daily administered bimatoprost vehicle ophthalmic solution for 2 weeks in ethnically Japanese patients with open-angle glaucoma or ocular hypertension

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Primary Completion: 2004-01
• Study Completion: 2004-01
• Status Verified: 2008-04
• Study First Submitted: 2008-04-01
• Study First Submitted QC: 2008-04-01
• Last Update Submitted: 2008-04-01
• Study First Posted: 2008-04-03
• Last Update Posted: 2008-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

Inclusion Criteria

• Ethnically Japanese patients with glaucoma or ocular hypertension in each eye who require IOP-lowering therapy in both eyes

Exclusion Criteria

• Uncontrolled systemic disease
• Use of bimatoprost or an ocular prostaglandin (eg, latanoprost, travoprost) within 6 weeks prior to baseline (Day 0)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Bimatoprost 0.01% Ophthalmic Solution	Bimatoprost 0.01% Ophthalmic Solution
2	Bimatoprost 0.03% Ophthalmic Solution	Bimatoprost 0.03% Ophthalmic Solution
3	Bimatoprost Vehicle Ophthalmic Solution	Bimatoprost Vehicle Ophthalmic Solution

Primary Outcome Measures

Name	Time	Method
Intraocular pressure (IOP)	Day 14

Secondary Outcome Measures

Name	Time	Method
IOP	Days 2 and 7