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Clinical Trials/NCT00651859
NCT00651859
Completed
Phase 2

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

Allergan0 sites111 target enrollmentStarted: November 2002Last updated:
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ConditionsGlaucomaOcular Hypertension
InterventionsBimatoprost 0.01% Ophthalmic SolutionBimatoprost 0.03% Ophthalmic SolutionBimatoprost Vehicle Ophthalmic Solution
DrugsBimatoprost 0.01% Ophthalmic SolutionBimatoprost 0.03% Ophthalmic SolutionBimatoprost Vehicle Ophthalmic Solution

Overview

Phase
Phase 2
Status
Completed
Sponsor
Allergan
Enrollment
111
Primary Endpoint
Intraocular pressure (IOP)
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

1

Experimental

Bimatoprost 0.01% Ophthalmic Solution

Intervention: Bimatoprost 0.01% Ophthalmic Solution (Drug)

2

Experimental

Bimatoprost 0.03% Ophthalmic Solution

Intervention: Bimatoprost 0.03% Ophthalmic Solution (Drug)

3

Placebo Comparator

Bimatoprost Vehicle Ophthalmic Solution

Intervention: Bimatoprost Vehicle Ophthalmic Solution (Drug)

Outcomes

Primary Outcomes

Intraocular pressure (IOP)

Time Frame: Day 14

Secondary Outcomes

  • IOP(Days 2 and 7)

Investigators

Sponsor
Allergan
Sponsor Class
Industry

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