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COMPLETEDPHASE1/PHASE2

A Study to Evaluate Efficacy and Safety of a Fixed Combination Ocular Insert in Participants With Open-angle Glaucoma or Ocular Hypertension

A Phase 1B, Multicenter, Randomized, Double-masked, Controlled Study to Evaluate the Efficacy and Safety of a Fixed Combination Bimatoprost/Timolol Ocular Insert Compared to Its Individual Components With Crossover to Timolol 0.5% in Subjects With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT)

NCT02742649•ForSight Vision5, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine if a combination of two drugs (bimatoprost and timolol) delivered to the surface of the eye over 10 weeks is better at lowering intraocular pressure (IOP) than either of the drugs delivered alone.

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
•IOP for each eye is ≥ 23 mmHg at T=0hr, ≥ 20 mmHg at T=4hr and T=8hr.
•Inter-eye IOP difference of ≤ 5.0 mmHg at T=0hr, T=4hr and T=8hr.
•IOP for each eye is ≤ 30 mmHg at T=0hr, T=4hr and T=8hr.

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 a topical beta-blocker
•Use of any agents known to have a substantial effect on IOP during planned study period (e.g. beta-blockers)
•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
+5 more criteria

Locations (1)

Clinica de Ojos Orillac - Calvo

Panama City, Panama

Key Dates

Start Date

April 30, 2016

Primary Completion Date

December 31, 2016

Completion Date

December 31, 2016

Last Updated

February 25, 2019

Enrollment

ACTUAL participants

Conditions

Open-Angle GlaucomaOcular Hypertension

Interventions

Fixed Combination

DRUG

Bimatoprost

DRUG

Timolol

DRUG

Placebo Segment

DEVICE

Timolol 0.5%

DRUG

DSLT for Reducing Medication in Glaucoma

NCT07390890

Primary Open Angle GlaucomaOcular Hypertension

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RECRUITINGNA

Direct Selective Laser Trabeculoplasty in Ethnic Chinese Population

NCT05902871

Primary Open Angle GlaucomaOcular Hypertension+1 more

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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: February 25, 2019Data 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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A Study to Evaluate Efficacy and Safety of a Fixed Combination Ocular Insert in Participants With Open-angle Glaucoma or Ocular Hypertension

Inclusion Criteria

Exclusion Criteria

DSLT for Reducing Medication in Glaucoma

Direct Selective Laser Trabeculoplasty in Ethnic Chinese Population

Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhone)

Association Between Limbal Function and Tear Proteomics in Chronic Ocular Diseases: Focusing on Glaucoma

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

24-hour Wear Performance and Safety Study of Smartlens miLens Contact Lens for IOP Monitoring