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

Allergan

Status and phase: Completed; Phase 2; Phase 1

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Treatments: Drug: bimatoprost 15 µg generation 2; Drug: bimatoprost 10 µg generation 1; Drug: bimatoprost 10 µg generation 2; Drug: bimatoprost 0.03%; Drug: bimatoprost 20 µg generation 2; Drug: bimatoprost 6 µg generation 2; Drug: bimatoprost 15 µg generation 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT01157364

2011-005091-42 (EudraCT Number)

192024-041D

Details and patient eligibility

About

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.

Enrollment: 109 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of open angle glaucoma or ocular hypertension

Exclusion criteria

• Uncontrolled medical conditions
• Anticipated wearing of contact lenses during the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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109 participants in 6 patient groups

bimatoprost 20 µg generation 2, bimatoprost 0.03%

Other group

Description:

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.

Treatment:

Drug: bimatoprost 0.03%

Drug: bimatoprost 20 µg generation 2

bimatoprost 15 µg generation 2, bimatoprost 0.03%

Other group

Description:

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.

Treatment:

Drug: bimatoprost 15 µg generation 2

Drug: bimatoprost 0.03%

bimatoprost 10 µg generation 2, bimatoprost 0.03%

Other group

Description:

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.

Treatment:

Drug: bimatoprost 0.03%

Drug: bimatoprost 10 µg generation 2

bimatoprost 6 µg generation 2, bimatoprost 0.03%

Other group

Description:

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.

Treatment:

Drug: bimatoprost 0.03%

Drug: bimatoprost 6 µg generation 2

bimatoprost 15 µg generation 1, bimatoprost 0.03%

Other group

Description:

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.

Treatment:

Drug: bimatoprost 0.03%

Drug: bimatoprost 15 µg generation 1

bimatoprost 10 µg generation 1, bimatoprost 0.03%

Other group

Description:

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.

Treatment:

Drug: bimatoprost 10 µg generation 1

Drug: bimatoprost 0.03%