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

Phase 1

Completed

• Conditions: Ocular Hypertension; Open-Angle Glaucoma
• Interventions: Drug: bimatoprost 20 µg generation 2; Drug: bimatoprost 6 µg generation 2; Drug: bimatoprost 15 µg generation 2; Drug: bimatoprost 10 µg generation 2; Drug: bimatoprost 15 µg generation 1; Drug: bimatoprost 10 µg generation 1; Drug: bimatoprost 0.03%

• Registration Number: NCT01157364
• Lead Sponsor: Allergan

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

Not available

Study Timeline

• Study First Submitted: 2010-07-02
• Study First Submitted QC: 2010-07-06
• Study First Posted: 2010-07-07
• Study Start: 2010-09-23
• Primary Completion: 2016-07-27
• Study Completion: 2016-08-09
• Disposition First Submitted: 2018-01-11
• Disposition First Submitted QC: 2018-01-11
• Disposition First Posted: 2018-01-16
• Results First Submitted: 2020-01-10
• Status Verified: 2020-03
• Results First Submitted QC: 2020-03-27
• Last Update Submitted: 2020-03-27
• Results First Posted: 2020-03-30
• Last Update Posted: 2020-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

• Diagnosis of open angle glaucoma or ocular hypertension

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bimatoprost 20 µg generation 2, bimatoprost 0.03%	bimatoprost 20 µg generation 2	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.
bimatoprost 6 µg generation 2, bimatoprost 0.03%	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). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
bimatoprost 15 µg generation 2, bimatoprost 0.03%	bimatoprost 15 µg generation 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.
bimatoprost 10 µg generation 2, bimatoprost 0.03%	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). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
bimatoprost 15 µg generation 1, bimatoprost 0.03%	bimatoprost 0.03%	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.
bimatoprost 10 µg generation 1, bimatoprost 0.03%	bimatoprost 0.03%	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.
bimatoprost 20 µg generation 2, bimatoprost 0.03%	bimatoprost 0.03%	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.
bimatoprost 10 µg generation 2, bimatoprost 0.03%	bimatoprost 0.03%	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.
bimatoprost 15 µg generation 2, bimatoprost 0.03%	bimatoprost 0.03%	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.
bimatoprost 15 µg generation 1, bimatoprost 0.03%	bimatoprost 15 µg generation 1	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.
bimatoprost 10 µg generation 1, bimatoprost 0.03%	bimatoprost 10 µg generation 1	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.
bimatoprost 6 µg generation 2, bimatoprost 0.03%	bimatoprost 0.03%	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye	Baseline, Month 24	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.

Secondary Outcome Measures

Name	Time	Method
Time-Matched Intraocular Pressure (IOP) in the Study Eye	Baseline to Month 6	IOP is a measurement of the fluid pressure inside the study eye.
Mean Diurnal IOP in the Study Eye	Baseline, Month 6	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.
Time to Rescue Treatment or Re-Treatment in the Study Eye	24 Months	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.

Trial Locations

Locations (57)

Sall Research Medical Center; 🇺🇸 Artesia, California, United States

Shiley Eye Center, Hamilton Glaucoma Center, University of California, San Diego; 🇺🇸 La Jolla, California, United States

Doheny Eye Institute; 🇺🇸 Los Angeles, California, United States

Martel Eye Medical Group; 🇺🇸 Rancho Cordova, California, United States

Shasta Eye Medical Group, Inc.; 🇺🇸 Redding, California, United States

Grutzmacher and Lewis, Inc.; 🇺🇸 Sacramento, California, United States

Pacific Eye Surgeons; 🇺🇸 San Luis Obispo, California, United States

Wolstan & Goldberg Eye Associates; 🇺🇸 Torrance, California, United States

Specialty Eye Care; 🇺🇸 Parker, Colorado, United States

The Eye Associates of Manatee; 🇺🇸 Bradenton, Florida, United States

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