Efficacy and Safety Study of Bimatoprost 0.01% Alone Compared With Travoprost 0.004% and Timolol 0.5% in Subjects With Glaucoma or Ocular Hypertension

December 9, 2015 updated by: Allergan
This efficacy and safety study will evaluate LUMIGAN® .01 (bimatoprost 0.01%) alone compared to TRAVATAN Z® (travoprost 0.004%) and TIMOLOL GFS, 0.5% (timolol 0.5% ophthalmic gel forming solution) in patients who require IOP lowering therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ocular hypertension or glaucoma that requires treatment with medication
  • Have a best corrected visual acuity (BCVA) of 20/100 or better in both eyes

Exclusion Criteria:

  • History of LASIK, LASEK, RK, and/or PRK in the study eye(s)
  • History of any intraocular surgery or glaucoma laser surgery in the study eye(s) within 3 months
  • Use of topical, periorbital, intravitreal or systemic steroid within 3 months or expected use during the course of study

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
Active Comparator: bimatoprost 0.01% and hypromellose 0.3%
Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
Drug: bimatoprost 0.01%
Bimatoprost 0.01% administered to both eyes once daily for 12 weeks.
Other Names:
  • Lumigan®
  • Lumigan® RC
Drug: hypromellose 0.3%
Hypromellose 0.3% lubricant eye drops (for masking purposes) administered to both eyes once daily for 12 weeks.
Other Names:
  • GenTeal®
Active Comparator: travoprost 0.004% and timolol 0.5%
Travoprost 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
Drug: timolol 0.5%
Timolol 0.5% administered to both eyes once daily for 12 weeks.
Other Names:
  • Timolol Maleate-EX
  • Timolol GFS
Drug: travoprost 0.004%
Travoprost 0.004% administered to both eyes once daily for 12 weeks.
Other Names:
  • Travatan Z®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM
Time Frame: Week 12 at 8 AM, 12 PM, and 4 PM
IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) is measured at 8 AM, 12 PM, and 4 PM. IOP is either the average of 2 measurements, or, if a third measurement is required, the average of 3 measurements.
Week 12 at 8 AM, 12 PM, and 4 PM

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

May 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

March 25, 2014

First Submitted That Met QC Criteria

March 25, 2014

First Posted (Estimate)

March 27, 2014

Study Record Updates

Last Update Posted (Estimate)

January 14, 2016

Last Update Submitted That Met QC Criteria

December 9, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMA-LUM-12-022

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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