NCT01157364

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Open-Angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	bimatoprost 20 µg generation 2	Single dose of bimatoprost ophthalmic administered in the study eye on Day 1.
DRUG	bimatoprost 15 µg generation 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).
DRUG	bimatoprost 10 µg generation 2	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).
DRUG	bimatoprost 6 µg generation 2	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).
DRUG	bimatoprost 15 µg generation 1	Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1.
DRUG	bimatoprost 10 µg generation 1	Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1.
DRUG	bimatoprost 0.03%	One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.

Timeline

• Start date: 2010-09-23
• Primary completion: 2016-07-27
• Completion: 2016-08-09
• First posted: 2010-07-07
• Last updated: 2020-03-30
• Results posted: 2020-03-30

Locations

57 sites across 10 countries: United States, Australia, Belgium, Brazil, Canada, Germany, Israel, Philippines, Singapore, Spain

Regulatory

• FDA-regulated drug study