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

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Twice-daily 0.01% Bimatoprost/0.15% Brimonidine/0.5% Timolol Ophthalmic Solution (Triple Combination) in Patients in India, Who Have Glaucoma or Ocular Hypertension With Elevated IOP, and Are on Twice-daily 0.2% Brimonidine/0.5% Timolol Ophthalmic Solution (Dual Combination) Therapy

Conditions
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Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Triple Combination Therapy<br>One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks. | Drug: bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution<br>* One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline, Week 12 |