Safety and Efficacy of Triple Combination Therapy in Patients With Glaucoma or Ocular Hypertension

Allergan

Status and phase: Completed; Phase 3

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01216943

192024-049

Details and patient eligibility

About

This study will investigate the safety and efficacy of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) in patients with glaucoma or ocular hypertension who have elevated intraocular pressure (IOP) on brimonidine/timolol ophthalmic solution.

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Glaucoma and/or ocular hypertension in both eyes
• Requires IOP-lowering treatment in both eyes

Exclusion criteria

• Other active ocular disease other than glaucoma or ocular hypertension (eg, uveitis, ocular infections or severe dry eye)
• Current or anticipated use of ocular medications other than study medications, except for intermittent use of artificial tears
• Use of oral, injectable or topical corticosteroids within 21 days
• Iridectomy or laser peripheral iridotomy in the study eye within 3 months
• Uncomplicated cataract surgery in the study eye within 6 months
• Incisional glaucoma surgery in the study eye within 12 months

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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126 participants in 1 patient group

Triple Combination Therapy

Experimental group

Description:

One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.

Treatment:

Drug: bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution