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

Allergan111 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

111

Conditions

Glaucoma Ocular Hypertension

Interventions

Bimatoprost 0.01% Ophthalmic SolutionDRUG

Bimatoprost 0.01% ophthalmic solution 1 drop instilled in each eye once daily in the evening between 19:00 and 21:00

Bimatoprost 0.03% Ophthalmic SolutionDRUG

Bimatoprost 0.03% ophthalmic solution 1 drop instilled in each eye once daily in the evening between 19:00 and 21:00

Bimatoprost Vehicle Ophthalmic SolutionDRUG

Bimatoprost vehicle ophthalmic solution 1 drop instilled in each eye once daily in the evening between 19:00 and 21:00

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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)

Locations (1)

Unnamed facility

San Francisco, California, United States

Outcomes

Primary Outcomes

Intraocular pressure (IOP)

Time frame: Day 14

Secondary Outcomes

IOP

Time frame: Days 2 and 7

Data from ClinicalTrials.gov

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