Overview

This trial is active, not recruiting.

Conditions glaucoma, open-angle, ocular hypertension
Treatments bimatoprost/brimonidine tartrate/timolol ophthalmic solution (triple combination therapy), fixed combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution
Phase phase 3
Sponsor Allergan
Start date January 2011
End date September 2014
Trial size 185 participants
Trial identifier NCT01217606, 192024-062

Summary

This study will evaluate the safety and efficacy of Triple Combination Therapy compared with Fixed Combination brimonidine tartrate/timolol ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
bimatoprost/brimonidine tartrate/timolol ophthalmic solution (triple combination therapy)
One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
(Active Comparator)
Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
fixed combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution COMBIGAN®
One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.

Primary Outcomes

Measure
Intraocular Pressure (IOP)
time frame: Week 12

Secondary Outcomes

Measure
IOP
time frame: Week 2
IOP
time frame: Week 4
IOP
time frame: Week 8
IOP
time frame: Week 1
IOP
time frame: Month 6
IOP
time frame: Month 9
IOP
time frame: Month 12

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Ocular hypertension or primary open-angle glaucoma in each eye - Requires treatment with IOP-lowering medication in both eyes Exclusion Criteria: - Required chronic use of ocular medications during the study other than study medication - Use of any corticosteroids within 30 days - History of any prior eye surgery, except for uncomplicated eye surgery performed more than 6 months before the Screening visit - Anticipated wearing of contact lenses during the study

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