An 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

Phase 4

Completed

• Conditions: Glaucoma; Ocular Hypertension
• Interventions: Drug: bimatoprost 0.01%; Drug: travatan 0.004%; Drug: timolol 0.5%; Drug: hypromellose 0.3%

• Registration Number: NCT01881126
• Lead Sponsor: Allergan

Brief Summary

This efficacy and safety study will evaluate LUMIGAN® RC/ LUMIGAN® .01 (bimatoprost 0.01%) alone compared to TRAVATAN Z® (travoprost 0.004%) and TIMOLOL MALEATE-EX, 0.5%/TIMOLOL GFS 0.5% (timolol 0.5% ophthalmic gel forming solution) in patients who require IOP lowering therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-17
• Study First Submitted QC: 2013-06-17
• Study First Posted: 2013-06-19
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-10
• Results First Submitted: 2015-10-27
• Results First Submitted QC: 2015-10-27
• Last Update Submitted: 2015-10-27
• Results First Posted: 2015-11-30
• Last Update Posted: 2015-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bimatoprost 0.01% and hypromellose 0.3%	bimatoprost 0.01%	Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
travatan 0.004% and timolol 0.5%	travatan 0.004%	Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
travatan 0.004% and timolol 0.5%	timolol 0.5%	Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
bimatoprost 0.01% and hypromellose 0.3%	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.

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM	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.