Overview

This trial is active, not recruiting.

Conditions glaucoma, ocular hypertension
Treatments bimatoprost 0.01%, travoprost 0.004%, timolol 0.5%, hypromellose 0.3%
Phase phase 4
Sponsor Allergan
Start date April 2014
End date November 2015
Trial size 100 participants
Trial identifier NCT02097719, GMA-LUM-12-022

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Active Comparator)
Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
bimatoprost 0.01% Lumigan® RC
Bimatoprost 0.01% administered to both eyes once daily for 12 weeks.
hypromellose 0.3% GenTeal®
Hypromellose 0.3% lubricant eye drops (for masking purposes) administered to both eyes once daily for 12 weeks.
(Active Comparator)
Travoprost 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
travoprost 0.004% Travatan Z®
Travoprost 0.004% administered to both eyes once daily for 12 weeks.
timolol 0.5% Timolol Maleate-EX
Timolol 0.5% administered to both eyes once daily for 12 weeks.

Primary Outcomes

Measure
Intraocular Pressure (IOP) in the Study Eye
time frame: Month 3

Eligibility Criteria

Male or female participants at least 18 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Allergan.