Safety and Efficacy of Triple Combination Therapy in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension

Allergan

Status and phase: Completed; Phase 3

Conditions: Ocular Hypertension; Glaucoma, Open-Angle

Treatments: Drug: bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy); Drug: Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01217606

192024-062

Details and patient eligibility

About

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.

Enrollment: 185 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 traumatic eye surgeries
• Cataract surgery in the past 6 months
• Anticipated wearing of contact lenses during the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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185 participants in 2 patient groups

Triple Combination Therapy

Experimental group

Description:

Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for up to 12 months.

Treatment:

Drug: bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy)

Combigan®

Active Comparator group

Description:

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 up to 12 months.

Treatment:

Drug: Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution