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

Allergan126 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

126

Conditions

Glaucoma Ocular Hypertension

Interventions

bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solutionDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Coimbatore, Tamil Nadu, India

Outcomes

Primary Outcomes

Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye

IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the mean of the IOP values at hour 0, hour 2 and hour 8 at each visit in the study eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).

Time frame: Baseline, Week 12

Data from ClinicalTrials.gov

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