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Dose-Ranging Study of the Bimatoprost Ocular Insert | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Dose-Ranging Study of the Bimatoprost Ocular Insert

A Phase 2 Prospective, Multicenter, Randomized, Double-masked, Controlled Study to Evaluate the Efficacy and Safety and Dose-response of the Bimatoprost Ocular Insert (2.2 mg, 13 mg) With and Without Concomitant Artificial Tears Compared to a Placebo Ocular Insert With and Without Concomitant Timolol (0.5%) Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension

NCT02358369•ForSight Vision5, Inc.

View on ClinicalTrials.gov

Summary

The Bimatoprost Ocular Insert is intended to provide sustained delivery of bimatoprost to the ocular surface to lower the intraocular pressure (IOP) in patients with Open-Angle Glaucoma or Ocular Hypertension. This study evaluated the safety and efficacy of two different doses of the Bimatoprost Ocular Insert, compared to an active control arm with timolol ophthalmic solution (0.5%).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Written informed consent
•At least 18 years of age
•Diagnosis in both eyes of either primary open-angle glaucoma (POAG) or ocular hypertension
•Best corrected-distance visual acuity score equivalent to 20/80 or better
•Stable visual field
•Central corneal thickness between 490 - 620 micrometers
•("T" is defined as time and "hr" is defined as hour\[s\])
•IOP for each eye is ≥ 23 mm Hg at T=0 hr, ≥ 20 mm Hg at T=2 hr and T=8 hr.
•Inter-eye IOP difference of ≤ 5.0 mm Hg at T=0 hr, T=2 hr and T=8 hr.
•IOP for each eye is ≤ 30 mm Hg at T=0 hr, T=2 hr and T=8 hr.

Exclusion Criteria

•Any known contraindication to prostaglandin analog (latanoprost, travoprost, bimatoprost, tafluprost) or timolol
•A cardiac or pulmonary condition that in the opinion of the Investigator would contraindicate the use of beta-blocker drops
•Cup-to-disc ratio of 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
•Ocular, orbital, and/or eyelid surgery of any type within the past six (6) months from screening date
•Laser surgery for glaucoma / ocular hypertension on one (1) or both eyes within the last six (6) months
•Past history of any incisional surgery for glaucoma at any time
•Past history of corneal refractive surgery
•Corneal abnormalities that would interfere with accurate IOP readings with an applanation tonometer
•Current participation in an investigational drug or device study or participation in such a study within 30 days of Screening
+4 more criteria

Locations (10)

Vold Vision

Fayetteville, Arkansas, United States

Sall Medical Research Center

Artesia, California, United States

Eye Research Foundation

Newport Beach, California, United States

Clayton Eye Center

Morrow, Georgia, United States

Mundorf Eye Center

Charlotte, North Carolina, United States

Cornerstone Health Care

High Point, North Carolina, United States

Apex Eye

Madeira, Ohio, United States

University of Eye Specialists

Maryville, Tennessee, United States

Total Eye Care

Memphis, Tennessee, United States

R&R Eye Research, LLC

San Antonio, Texas, United States

Key Dates

Start Date

January 19, 2015

Primary Completion Date

August 31, 2015

Completion Date

October 7, 2015

Last Updated

June 4, 2020

Enrollment

156

ACTUAL participants

Conditions

Primary Open-Angle GlaucomaOcular Hypertension

Interventions

Bimatoprost

DRUG

Timolol 0.5%

DRUG

Placebo Ocular Insert

DEVICE

Placebo Eye Drops

DRUG

DSLT for Reducing Medication in Glaucoma

NCT07390890

Primary Open Angle GlaucomaOcular Hypertension

View study

RECRUITINGNA

Direct Selective Laser Trabeculoplasty in Ethnic Chinese Population

NCT05902871

Primary Open Angle GlaucomaOcular Hypertension+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 4, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Dose-Ranging Study of the Bimatoprost Ocular Insert

Inclusion Criteria

Exclusion Criteria

DSLT for Reducing Medication in Glaucoma

Direct Selective Laser Trabeculoplasty in Ethnic Chinese Population

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Effect of Rhopressa on Intraocular Pressure (IOP) in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension Post-SLT

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