Safety and Efficacy Study of Different Formulations of Bimatoprost Once-Daily in Patients With Glaucoma or Ocular Hypertension

Study Overview
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Brief Summary
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This study evaluates the safety and efficacy of different formulations of bimatoprost ophthalmic solution compared with Bimatoprost 0.03% once-daily in patients with glaucoma or ocular hypertension. One of the test formulations was given to one eye and bimatoprost 0.03% given to the fellow eye of each patient

Conditions
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Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Bimatoprost 0.01% ophthalmic solution
* Drug: Bimatoprost 0.015% formulation 1 ophthalmic solution
* Drug: Bimatoprost 0.015% formulation 2 ophthalmic solution
* Drug: Bimatoprost 0.02% ophthalmic solution
* Drug: Bimatoprost 0.03% ophthalmic solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ocular hypertension or glaucoma in both eyes Require IOP-lowering therapy in each eye Exclusion Criteria: Uncontrolled systemic disease Known allergy or hypersensitivity to bimatoprost

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: 1<br>Bimatoprost 0.01% ophthalmic solution | Drug: Bimatoprost 0.01% ophthalmic solution<br>* One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop<br>|
| Experimental: 2<br>Bimatoprost 0.015% formulation 1 ophthalmic solution | Drug: Bimatoprost 0.015% formulation 1 ophthalmic solution<br>* One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop<br>|
| Experimental: 3<br>Bimatoprost 0.015% formulation 2 ophthalmic solution | Drug: Bimatoprost 0.015% formulation 2 ophthalmic solution<br>* One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop<br>|
| Experimental: 4<br>Bimatoprost 0.02% ophthalmic solution | Drug: Bimatoprost 0.02% ophthalmic solution<br>* One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop<br>|
| Active Comparator: 5<br>Bimatoprost 0.03% ophthalmic solution | Drug: Bimatoprost 0.03% ophthalmic solution<br>* Bimatoprost 0.03% ophthalmic solution, one drop in one eye, once daily in the morning for 4 consecutive days, the other eye received one drop of any of the 4 study drugs<br>* Other names: LUMIGAN®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure (IOP) |  | Day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Comfort |  | Days 1-4 | 
| Patient Satisfaction |  | Day 5 | 
| Treatment Preference |  | Day 5 |