Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension

Study Overview
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Brief Summary
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This study will evaluate the safety and efficacy of new ophthalmic formulations of bimatoprost in patients with open angle glaucoma and ocular hypertension. At least 3 dose strengths will be evaluated based on internal data review of each cohort. The study was planned to be conducted in 2 stages. Stage 1 was an open-label and Stage 2 was planned to be masked; however only Stage 1 was conducted.

Official Title
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An Open-label (Stage 1) and Randomized (Stage 2), 24 Month Study of Safety and Efficacy of Bimatoprost Drug Delivery System in Patients With Open-Angle Glaucoma or Ocular Hypertension

Conditions
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Open-Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: bimatoprost 20 µg generation 2
* Drug: bimatoprost 15 µg generation 2
* Drug: bimatoprost 10 µg generation 2
* Drug: bimatoprost 6 µg generation 2
* Drug: bimatoprost 15 µg generation 1
* Drug: bimatoprost 10 µg generation 1
* Drug: bimatoprost 0.03%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of open angle glaucoma or ocular hypertension Exclusion Criteria: Uncontrolled medical conditions Anticipated wearing of contact lenses during the study

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: bimatoprost 20 µg generation 2, bimatoprost 0.03%<br>Single dose of bimatoprost ophthalmic 20 µg generation 2 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. | Drug: bimatoprost 20 µg generation 2<br>* Single dose of bimatoprost ophthalmic administered in the study eye on Day 1.<br>Drug: bimatoprost 0.03%<br>* One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.<br>* Other names: LUMIGAN®;|
| Other: bimatoprost 15 µg generation 2, bimatoprost 0.03%<br>Single dose of bimatoprost ophthalmic 15 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. | Drug: bimatoprost 15 µg generation 2<br>* Single dose of bimatoprost ophthalmic administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).<br>Drug: bimatoprost 0.03%<br>* One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.<br>* Other names: LUMIGAN®;|
| Other: bimatoprost 10 µg generation 2, bimatoprost 0.03%<br>Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. | Drug: bimatoprost 10 µg generation 2<br>* Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).<br>Drug: bimatoprost 0.03%<br>* One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.<br>* Other names: LUMIGAN®;|
| Other: bimatoprost 6 µg generation 2, bimatoprost 0.03%<br>Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. | Drug: bimatoprost 6 µg generation 2<br>* Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).<br>Drug: bimatoprost 0.03%<br>* One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.<br>* Other names: LUMIGAN®;|
| Other: bimatoprost 15 µg generation 1, bimatoprost 0.03%<br>Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. | Drug: bimatoprost 15 µg generation 1<br>* Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1.<br>Drug: bimatoprost 0.03%<br>* One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.<br>* Other names: LUMIGAN®;|
| Other: bimatoprost 10 µg generation 1, bimatoprost 0.03%<br>Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. | Drug: bimatoprost 10 µg generation 1<br>* Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1.<br>Drug: bimatoprost 0.03%<br>* One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.<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 Time-Matched Intraocular Pressure (IOP) in the Study Eye | IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. | Baseline, Month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-Matched Intraocular Pressure (IOP) in the Study Eye | IOP is a measurement of the fluid pressure inside the study eye. | Baseline to Month 6 | 
| Mean Diurnal IOP in the Study Eye | IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0, 2, 4, 6, and 8 and averaged to determine the mean diurnal IOP. | Baseline, Month 6 | 
| Time to Rescue Treatment or Re-Treatment in the Study Eye | Time to rescue treatment or the second treatment in the generation 2 groups is defined as the time between the first treatment and the second treatment in the study eye. | 24 Months |