Safety and Efficacy of Different Formulations of Bimatoprost 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 0.03% formulation B ophthalmic solution with LUMIGAN® (bimatoprost ophthalmic solution 0.03%) 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 0.03% Formulation B Ophthalmic Solution
* Drug: Bimatoprost 0.03% 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 0.03% Formulation B Ophthalmic Solution<br>Bimatoprost 0.03% Formulation B Ophthalmic Solution | Drug: Bimatoprost 0.03% Formulation B Ophthalmic Solution<br>* One drop administered in each eye, every evening, for 12 weeks<br>|
| Active Comparator: Bimatoprost 0.03% Ophthalmic Solution<br>Bimatoprost 0.03% Ophthalmic Solution | Drug: Bimatoprost 0.03% Ophthalmic Solution<br>* One drop administered in each eye, every evening, for 12 weeks<br>* Other names: LUMIGAN®;|

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 Week 12 | Change from baseline in worse eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements in the worse eye were evaluated at hours 0, 2, and 8. A negative number change from baseline indicated a reduction in IOP, and a positive number change from baseline indicated an increase in IOP. | Baseline, Week 12 | 
| Average Eye IOP at Week 12 | Average Eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. Baseline data are included for reference only. | Baseline, Week 12 | 
| Average Eye IOP at Week 6 | Average Eye IOP at Week 6 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. | Week 6 | 
| Average Eye IOP at Week 2 | Average Eye IOP at Week 2 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. | Week 2 |