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

April 1, 2008 updated by: Allergan
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

249

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Bimatoprost 0.01% ophthalmic solution
Drug: 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
Experimental: 2
Bimatoprost 0.015% formulation 1 ophthalmic solution
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
Experimental: 3
Bimatoprost 0.015% formulation 2 ophthalmic solution
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
Experimental: 4
Bimatoprost 0.02% ophthalmic solution
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
Active Comparator: 5
Bimatoprost 0.03% ophthalmic solution
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
Other Names:
  • LUMIGAN®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intraocular pressure (IOP)
Time Frame: Day 5
Day 5

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient Comfort
Time Frame: Days 1-4
Days 1-4
Patient Satisfaction
Time Frame: Day 5
Day 5
Treatment Preference
Time Frame: Day 5
Day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

May 1, 2005

Study Completion (Actual)

May 1, 2005

Study Registration Dates

First Submitted

April 1, 2008

First Submitted That Met QC Criteria

April 1, 2008

First Posted (Estimate)

April 3, 2008

Study Record Updates

Last Update Posted (Estimate)

April 3, 2008

Last Update Submitted That Met QC Criteria

April 1, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 192024-030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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