A Safety and Efficacy Study of Fixed-Combination Bimatoprost and Brimonidine in Chronic Glaucoma or Ocular Hypertension

Study Overview
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Brief Summary
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This is a safety and efficacy study of fixed-combination bimatoprost and brimonidine compared with LUMIGAN® and ALPHAGAN® in patients with chronic glaucoma or ocular hypertension.

Conditions
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Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Fixed-Combination Bimatoprost/Brimonidine
* Drug: Bimatoprost Ophthalmic Solution 0.01%
* Drug: Vehicle Ophthalmic Solution
* Drug: Brimonidine Tartrate Ophthalmic Solution 0.2%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of ocular hypertension or glaucoma Requires intraocular pressure (IOP)-lowering therapy Exclusion Criteria: Cataract surgery in one eye Ocular laser or intraocular surgery within 6 months Refractive surgery in either eye Anticipated use of contact lenses during the study Expected use of artificial tears during the study

Ages Eligible for Study
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Minimum Age: 40 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fixed-Combination Bimatoprost/Brimonidine<br>One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks. | Drug: Fixed-Combination Bimatoprost/Brimonidine<br>* One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.<br>|
| Active Comparator: Bimatoprost Ophthalmic Solution 0.01% and Vehicle<br>One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks. | Drug: Bimatoprost Ophthalmic Solution 0.01%<br>* One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening for 6 weeks.<br>* Other names: LUMIGAN;Drug: Vehicle Ophthalmic Solution<br>* One drop vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.<br>|
| Active Comparator: Brimonidine Tartrate Ophthalmic Solution 0.2%<br>One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks. | Drug: Brimonidine Tartrate Ophthalmic Solution 0.2%<br>* One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.<br>* Other names: ALPHAGAN;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Average Eye Mean Diurnal Intraocular Pressure (IOP) | IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. 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, Day 42 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Average Eye Mean Diurnal IOP | IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. 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, Day 14, Day 28 | 
| Average Eye Mean Diurnal IOP | IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. | Day 14, Day 28, Day 42 |