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

Allergan

Status and phase: Completed; Phase 4

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: bimatoprost 0.01%; Drug: timolol 0.5%; Drug: travatan 0.004%; Drug: hypromellose 0.3%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01881126

GMA-LUM-12-021

Details and patient eligibility

About

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.

Enrollment: 93 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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93 participants in 2 patient groups

bimatoprost 0.01% and hypromellose 0.3%

Active Comparator group

Description:

Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.

Treatment:

Drug: hypromellose 0.3%

Drug: bimatoprost 0.01%

travatan 0.004% and timolol 0.5%

Active Comparator group

Description:

Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.

Treatment:

Drug: travatan 0.004%

Drug: timolol 0.5%