Bimatoprost 0.03% Versus Travoprost 0.004% in Patients Currently on Latanoprost 0.005%

April 10, 2019 updated by: Allergan
Patients with glaucoma or ocular hypertension currently being treated with latanoprost 0.005%, and in need of additional IOP lowering, will be randomized to receive either bimatoprost 0.03% or travoprost 0.004% in place of latanoprost 0.005%

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

266

Phase

  • Phase 4

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:

  • Glaucoma or ocular hypertension in both eyes
  • Currently being treated with latanoprost 0.005% daily and in need of additional IOP-lowering
  • Best-corrected visual acuity of 20/100 or better in each eye
  • Visual field within 6 months of study entry

Exclusion Criteria:

  • Secondary glaucoma
  • Active intraocular inflammation or macular edema
  • Intraocular surgery or laser surgery within the past 3 months

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: bimatoprost 0.03% eye drops
bimatoprost 0.03% 1 drop nightly for 3 months
Other Names:
  • Lumigan®
Active Comparator: 2
Drug: travoprost 0.004% eye drops
travoprost 0.004% 1 drop nightly for 3 months
Other Names:
  • Travatan®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular Pressure (IOP)
Time Frame: Month 3
Intraocular Pressure
Month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerability - Conjunctival Hyperemia
Time Frame: Month 3
Conjunctival Hyperemia: Number of participants with at least 1 grade increase in severity from baseline. A five grade scale from 0 to 3 (0 = none, +0.5 = trace, 1 = mild, 2 = moderate, 3 = severe)
Month 3

Collaborators and Investigators

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

Sponsor

Allergan

Investigators

  • Study Director: Medical Affairs, Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2006

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

February 22, 2007

First Submitted That Met QC Criteria

February 22, 2007

First Posted (Estimate)

February 26, 2007

Study Record Updates

Last Update Posted (Actual)

April 25, 2019

Last Update Submitted That Met QC Criteria

April 10, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MA-LUM01

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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