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Safety and Efficacy Study of Different Formulations of Bimatoprost Once-Daily in Patients With Glaucoma or Ocular Hypertension

NCT ID: NCT00652496

Last Updated: 2008-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

249 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2005-05-31

Brief Summary

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This study evaluates the safety and efficacy of different formulations of bimatoprost ophthalmic solution compared with Bimatoprost 0.03% once-daily in patients with glaucoma or ocular hypertension. One of the test formulations was given to one eye and bimatoprost 0.03% given to the fellow eye of each patient

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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1

Bimatoprost 0.01% ophthalmic solution

Group Type EXPERIMENTAL

Bimatoprost 0.01% ophthalmic solution

Intervention Type DRUG

One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop

2

Bimatoprost 0.015% formulation 1 ophthalmic solution

Group Type EXPERIMENTAL

Bimatoprost 0.015% formulation 1 ophthalmic solution

Intervention Type DRUG

One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop

3

Bimatoprost 0.015% formulation 2 ophthalmic solution

Group Type EXPERIMENTAL

Bimatoprost 0.015% formulation 2 ophthalmic solution

Intervention Type DRUG

One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop

4

Bimatoprost 0.02% ophthalmic solution

Group Type EXPERIMENTAL

Bimatoprost 0.02% ophthalmic solution

Intervention Type DRUG

One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop

5

Bimatoprost 0.03% ophthalmic solution

Group Type ACTIVE_COMPARATOR

Bimatoprost 0.03% ophthalmic solution

Intervention Type DRUG

Bimatoprost 0.03% ophthalmic solution, one drop in one eye, once daily in the morning for 4 consecutive days, the other eye received one drop of any of the 4 study drugs

Interventions

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Bimatoprost 0.01% ophthalmic solution

One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop

Intervention Type DRUG

Bimatoprost 0.015% formulation 1 ophthalmic solution

One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop

Intervention Type DRUG

Bimatoprost 0.015% formulation 2 ophthalmic solution

One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop

Intervention Type DRUG

Bimatoprost 0.02% ophthalmic solution

One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop

Intervention Type DRUG

Bimatoprost 0.03% ophthalmic solution

Bimatoprost 0.03% ophthalmic solution, one drop in one eye, once daily in the morning for 4 consecutive days, the other eye received one drop of any of the 4 study drugs

Intervention Type DRUG

Other Intervention Names

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LUMIGAN®

Eligibility Criteria

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Inclusion Criteria

* Ocular hypertension or glaucoma in both eyes
* Require IOP-lowering therapy in each eye

Exclusion Criteria

* Uncontrolled systemic disease
* Known allergy or hypersensitivity to bimatoprost
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Allergan, Inc.

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Wenatchee, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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192024-030

Identifier Type: -

Identifier Source: org_study_id