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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2, Multicenter, Randomized, Subject- and Examiner-masked, Controlled Clinical Trial Designed to Evaluate the Safety and Effectiveness of the Bimatoprost Ocular Insert as Compared to Topical Timolol Solution (0.5%) in Patients With Glaucoma or Ocular Hypertension.

Conditions
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Primary Open-Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Bimatoprost
* Drug: Timolol 0.5%
* Drug: Placebo Eye Drops
* Device: Placebo Ocular Insert


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Written informed consent Primary open-angle glaucoma or ocular hypertension in both eyes Best-corrected distance vision of 20/80 or better Stable visual field corneal thickness between 490-620 micrometers 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 13 mg Bimatoprost Ocular Insert<br>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. | Drug: Bimatoprost<br>* Bimatoprost ocular insert<br>Drug: Placebo Eye Drops<br>* Placebo topical eye drops<br>Device: Placebo Ocular Insert<br>* Ocular insert without any active drug<br>* Other names: non-medicated (placebo) Ocular Insert;|
| Active Comparator: Timolol 0.5% + Placebo Ocular Insert<br>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. | Drug: Timolol 0.5%<br>* Timolol 0.5% solution<br>* Other names: timoptic;Device: Placebo Ocular Insert<br>* Ocular insert without any active drug<br>* Other names: non-medicated (placebo) Ocular Insert;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Intra-Ocular Pressure (IOP) at 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. | Baseline (Day 0) to Week 2 | 
| Change From Baseline in Intra-Ocular Pressure (IOP) at 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. | Baseline (Day 0) to Week 6 | 
| Change From Baseline in Intra-Ocular Pressure (IOP) at 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. | Baseline (Day 0) to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in IOP at 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. | Baseline (Day 1) to Month 4 | 
| Change From Baseline in IOP at 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. | Baseline (Day 0) to Month 5 | 
| Change From Baseline in IOP at 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. | Baseline (Day 0) to Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma, Primary Open-Angle Glaucoma, Ocular Hypertension