Bimatoprost Ocular Insert Compared to Topical Timolol Solution in Patients With Glaucoma or Ocular Hypertension

Phase 2

Completed

Interventions: Drug: Timolol 0.5%
Drug: Bimatoprost
Drug: Placebo Eye Drops
Device: Placebo Ocular Insert

Brief Summary: The objective of this Phase 2 study is to evaluate whether the Bimatoprost Ocular Insert is non-inferior to that of timolol ophthalmic solution (0.5%) at 12 weeks.

Recruitment & Eligibility

Inclusion Criteria

Key

Exclusion Criteria

Cup-to-disc ratio greater than 0.8
significant risk of angle closure due to pupil dilation, defined as a Shaffer classification of less than grade 2 based on gonioscopy
laser surgery for glaucoma/ocular hypertension on one or both eyes within the last 12 months
past history of corneal refractive surgery
past history of any incisional surgery for glaucoma at any time
corneal abnormalities that would interfere with tonometry readings
current participation in an investigational drug or device study or participation in such a study within 30 days of screening
Inability to accurately evaluate the retina

Arm && Interventions

Group	Intervention	Description
Timolol 0.5% + Placebo Ocular Insert	Timolol 0.5%	Washout and placebo ocular insert in each eye for at least 4 weeks, followed by Timolol (timoptic ophthalmic solution 0.5%) twice a day in each eye plus placebo ocular insert for 6 months.
13 mg Bimatoprost Ocular Insert	Placebo Ocular Insert	Washout and placebo ocular insert in each eye for at least 4 weeks, followed by 13 mg Bimatoprost Ocular Insert in each eye and placebo eye drops twice a day in each eye for 6 months.
Timolol 0.5% + Placebo Ocular Insert	Placebo Ocular Insert	Washout and placebo ocular insert in each eye for at least 4 weeks, followed by Timolol (timoptic ophthalmic solution 0.5%) twice a day in each eye plus placebo ocular insert for 6 months.
13 mg Bimatoprost Ocular Insert	Placebo Eye Drops	Washout and placebo ocular insert in each eye for at least 4 weeks, followed by 13 mg Bimatoprost Ocular Insert in each eye and placebo eye drops twice a day in each eye for 6 months.
13 mg Bimatoprost Ocular Insert	Bimatoprost	Washout and placebo ocular insert in each eye for at least 4 weeks, followed by 13 mg Bimatoprost Ocular Insert in each eye and placebo eye drops twice a day in each eye for 6 months.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Intra-Ocular Pressure (IOP) at Week 2	Baseline (Day 0) to Week 2	IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (time (T)=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 2. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.
Change From Baseline in Intra-Ocular Pressure (IOP) at Week 6	Baseline (Day 0) to Week 6	IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 6. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.
Change From Baseline in Intra-Ocular Pressure (IOP) at Week 12	Baseline (Day 0) to Week 12	IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 12. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in IOP at Month 4	Baseline (Day 1) to Month 4	IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Month 4. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.
Change From Baseline in IOP at Month 5	Baseline (Day 0) to Month 5	IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Month 5. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.
Change From Baseline in IOP at Month 6	Baseline (Day 0) to Month 6	IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Month 6. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.

Locations (10): Sall Medical Research Center
🇺🇸
Artesia, California, United States
Scripps Clinic Torrey Pines
🇺🇸
La Jolla, California, United States
Eye Research Foundation
🇺🇸
Newport Beach, California, United States
UC Davis Dept of Ophthalmology & Vision Science
🇺🇸
Sacramento, California, United States
Coastal Research Associates
🇺🇸
Atlanta, Georgia, United States
Clayton Eye Center
🇺🇸
Morrow, Georgia, United States
Ophthalmology Consultants
🇺🇸
Saint Louis, Missouri, United States
UNC Kittner Eye Center
🇺🇸
Chapel Hill, North Carolina, United States
Apex Eye
🇺🇸
Madeira, Ohio, United States
Ophthalmology Associates PC
🇺🇸
Fort Worth, Texas, United States
Sall Medical Research Center
🇺🇸Artesia, California, United States