Safety and Efficacy of a New Formulation of Bimatoprost/Timolol Ophthalmic Solution Compared With Bimatoprost/Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

Study Overview
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Brief Summary
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This study will evaluate the safety and efficacy of bimatoprost/timolol formulation A ophthalmic solution with Ganfort® (bimatoprost 0.03%/timolol 0.5% ophthalmic solution) once daily for 12 weeks in patients with glaucoma or ocular hypertension.

Conditions
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Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: bimatoprost /timolol formulation A fixed combination ophthalmic solution
* Drug: bimatoprost/timolol fixed combination ophthalmic solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has ocular hypertension or glaucoma in both eyes Requires IOP-lowering therapy in each eye Exclusion Criteria: Active or recurrent eye disease that would interfere with interpretation of study data in either eye History of any eye surgery or laser in either eye within 6 months Required chronic use of other eye medications during the study Anticipated wearing of contact lenses during the study. Intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bimatoprost/timolol formulation A<br>One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks. | Drug: bimatoprost /timolol formulation A fixed combination ophthalmic solution<br>* One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.<br>|
| Active Comparator: bimatoprost/timolol fixed combination ophthalmic solution<br>One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks. | Drug: bimatoprost/timolol fixed combination ophthalmic solution<br>* One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.<br>* Other names: GANFORT®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 | Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement). | Baseline, Week 12 | 
| Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2 | Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 2 at Hour 0, Hour 2 and Hour 8. | Week 2 | 
| Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6 | Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 6 at Hour 0, Hour 2 and Hour 8. | Week 6 | 
| Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 | Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 12 at Hour 0, Hour 2 and Hour 8. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12 | Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement). | Baseline, Week 12 | 
| Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12 | Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8. Average eye IOP is defined as the average of the IOP in both eyes. A negative number change from baseline indicates a reduction in IOP (improvement). | Baseline, Week 12 |