Conditions: Open-Angle Glaucoma Ocular Hypertension
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 109
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: 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. arm 2: 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. arm 3: 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. arm 4: 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. arm 5: 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. arm 6: 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.

Interventions: intervention 1: bimatoprost 20 µg generation 2 intervention 2: bimatoprost 15 µg generation 2 intervention 3: bimatoprost 10 µg generation 2 intervention 4: bimatoprost 6 µg generation 2 intervention 5: bimatoprost 15 µg generation 1 intervention 6: bimatoprost 10 µg generation 1 intervention 7: bimatoprost 0.03%
Intervention descriptions: intervention 1: Single dose of bimatoprost ophthalmic administered in the study eye on Day 1. intervention 2: 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). intervention 3: 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). intervention 4: 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). intervention 5: Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1. intervention 6: Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1. intervention 7: One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.

Protocol document: