Safety and Efficacy of Brimonidine Tartrate/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension

Allergan

Status: Completed

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: brimonidine tartrate ophthalmic solution; Drug: brimonidine tartrate/timolol fixed combination ophthalmic solution; Other: fixed combination vehicle; Drug: timolol ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01229462

190342-035

Details and patient eligibility

About

This study will evaluate the safety and efficacy of brimonidine tartrate/timolol fixed combination (Combigan®) compared with brimonidine tartrate (Alphagan®) and timolol in patients with glaucoma or ocular hypertension who do not respond well to topical beta blockers.

Enrollment: 238 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Open-angle glaucoma or ocular hypertension in at least one eye that is not responsive to topical beta blockers
• No anticipated wearing of contact lenses during study

Exclusion criteria

• Active ocular disease other than glaucoma or ocular hypertension (eg, uveitis, ocular infections or severe dry eye)
• Any intraocular surgery or laser (eg, cataract surgery or Lasik) within 3 months
• Required regular use of other ocular medications except for occasional use of artificial tears

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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238 participants in 2 patient groups

Combigan®

Other group

Description:

One drop of brimonidine tartrate/timolol combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.

Treatment:

Other: fixed combination vehicle

Drug: brimonidine tartrate/timolol fixed combination ophthalmic solution

Alphagan® and Timolol Concurrent

Active Comparator group

Description:

One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.

Treatment:

Drug: timolol ophthalmic solution

Drug: brimonidine tartrate ophthalmic solution