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

Phase 2CompletedNCT01915940

ForSight Vision5, Inc.169 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

169

Conditions

Primary Open-Angle Glaucoma Ocular Hypertension

Interventions

BimatoprostDRUG

Bimatoprost ocular insert

Timolol 0.5%DRUG

Timolol 0.5% solution

Placebo Eye DropsDRUG

Placebo topical eye drops

Placebo Ocular Insert

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline (Day 0) to Week 12

Secondary Outcomes

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.

Time frame: 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.

Data from ClinicalTrials.gov

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