Efficacy and Safety Study of Bimatoprost Sustained-Release (SR) in Participants With Open-angle Glaucoma or Ocular Hypertension

Phase 3

Completed

• Conditions: Glaucoma, Open-Angle; Ocular Hypertension
• Interventions: Drug: Bimatoprost SR; Drug: Timolol Vehicle (placebo)

• Registration Number: NCT02247804
• Lead Sponsor: Allergan

Brief Summary

This study will evaluate the efficacy and safety of bimatoprost SR in participants with open-angle glaucoma or ocular hypertension. The study includes a 12-month treatment period with an 8-month extended follow-up.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-22
• Study First Submitted QC: 2014-09-22
• Study First Posted: 2014-09-25
• Study Start: 2014-12-15
• Primary Completion: 2018-02-19
• Disposition First Submitted: 2019-02-07
• Disposition First Submitted QC: 2019-02-07
• Disposition First Posted: 2019-02-12
• Study Completion: 2019-07-19
• Results First Submitted: 2020-04-03
• Results First Submitted QC: 2020-04-03
• Results First Posted: 2020-04-24
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-29
• Last Update Posted: 2020-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 594

Inclusion Criteria

-Diagnosis of either open-angle glaucoma or ocular hypertension in each eye and both eyes require IOP-lowering treatment.

Exclusion Criteria

• Previous enrollment in another Allergan Bimatoprost SR Study.
• Eye surgery (including cataract surgery) and/or any eye laser surgery within the past 6 months in the study eye
• Anticipated need for laser eye surgery in either eye within the first 52 weeks of the study duration
• History of glaucoma surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bimatoprost SR 15 μg	Bimatoprost SR	Study Eye: bimatoprost sustained release (SR) 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
Bimatoprost SR 15 μg	Timolol Vehicle (placebo)	Study Eye: bimatoprost sustained release (SR) 15 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
Bimatoprost SR 10 μg	Bimatoprost SR	Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
Bimatoprost SR 10 μg	Timolol Vehicle (placebo)	Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.

Primary Outcome Measures

Name	Time	Method
IOP in the Study Eye at Week 2 (Hour 2)	Week 2 (Hour 2)	IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
IOP in the Study Eye at Week 12 (Hour 0)	Week 12 (Hour 0)	IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
IOP in the Study Eye at Week 2 (Hour 0)	Week 2 (Hour 0)	IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
Change From Baseline in IOP in the Study Eye at Week 12 (Hours 0 and 2)	Baseline (Hours 0 and 2) to Week 12 (Hours 0 and 2)	IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. A mixed-effects model with repeated measures (MMRM) was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
IOP in the Study Eye at Week 6 (Hour 0)	Week 6 (Hour 0)	IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
IOP in the Study Eye at Week 6 (Hour 2)	Week 6 (Hour 2)	IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
IOP in the Study Eye at Week 12 (Hour 2)	Week 12 (Hour 2)	IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in IOP in the Study Eye	Baseline (Hours 0 and 2) to Weeks 2 and 6 (Hours 0 and 2)	IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.

Trial Locations

Locations (106)

Arizona Glaucoma Specialists; 🇺🇸 Phoenix, Arizona, United States

Lugene Eye Institute; 🇺🇸 Glendale, California, United States

Lakeside Vision Center; 🇺🇸 Irvine, California, United States

Hamilton Glaucoma Center, Shiley Eye Center UCSD; 🇺🇸 La Jolla, California, United States

Atlantis Eye Care; 🇺🇸 Long Beach, California, United States

Glaucoma Institute of Beverly Hills; 🇺🇸 Los Angeles, California, United States

Montebello Medical Eye Center Inc.; 🇺🇸 Montebello, California, United States

Stanford University; 🇺🇸 Palo Alto, California, United States

Foothill Eye Institute; 🇺🇸 Pasadena, California, United States

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

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