NCT01881126

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	bimatoprost 0.01%	Bimatoprost 0.01% administered to both eyes once daily for 12 weeks.
DRUG	travatan 0.004%	Travatan 0.004% 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.
DRUG	hypromellose 0.3%	Hypromellose 0.3% lubricant eye drops (for masking purposes) administered to both eyes once daily for 12 weeks.

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2013-06-19
• Last updated: 2015-11-30
• Results posted: 2015-11-30

Locations

2 sites across 1 country: Canada