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

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Racine, Wisconsin, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bimatoprost 0.01%

Drug

Bimatoprost 0.01% administered to both eyes once daily for 12 weeks.

Other names: Lumigan® RC, Lumigan®

Travoprost 0.004%

Drug

Travoprost 0.004% administered to both eyes once daily for 12 weeks.

Other names: Travatan Z®

Timolol 0.5%

Drug

Timolol 0.5% administered to both eyes once daily for 12 weeks.

Other names: Timolol Maleate-EX, Timolol GFS

hypromellose 0.3%

Drug

Hypromellose 0.3% lubricant eye drops (for masking purposes) administered to both eyes once daily for 12 weeks.

Other names: GenTeal®

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Mar 27, 2014
Registry last updated: Jan 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed