Safety and Efficacy of Different Formulations of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

597 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-01

Study Completion Date

2011-04-29

Brief Summary

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This study will evaluate the safety and efficacy of bimatoprost 0.03% formulation B ophthalmic solution with LUMIGAN® (bimatoprost ophthalmic solution 0.03%) once daily for 12 weeks in patients with glaucoma or ocular hypertension

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Detailed Description

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Conditions

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Glaucoma Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Bimatoprost 0.03% Formulation B Ophthalmic Solution

Group Type EXPERIMENTAL

Bimatoprost 0.03% Formulation B Ophthalmic Solution

Intervention Type DRUG

One drop administered in each eye, every evening, for 12 weeks

Bimatoprost 0.03% Ophthalmic Solution

Group Type ACTIVE_COMPARATOR

Bimatoprost 0.03% Ophthalmic Solution

Intervention Type DRUG

One drop administered in each eye, every evening, for 12 weeks

Interventions

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Bimatoprost 0.03% Formulation B Ophthalmic Solution

One drop administered in each eye, every evening, for 12 weeks

Intervention Type DRUG

Bimatoprost 0.03% Ophthalmic Solution

One drop administered in each eye, every evening, for 12 weeks

Intervention Type DRUG

Other Intervention Names

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LUMIGAN®

Eligibility Criteria

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Inclusion Criteria

* Patient has ocular hypertension or glaucoma in both eyes
* Requires IOP-lowering therapy in each eye

Exclusion Criteria

* Active or recurrent eye disease that would interfere with interpretation of study data in either eye
* History of any eye surgery or laser in either eye within 6 months
* Required chronic use of other eye medications during the study
* Anticipated wearing of contact lenses during the study.
* Intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No