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An Open-label Extension Study to Evaluate the Safety of the 13 mg Bimatoprost Ocular Insert | Clinical Trials | Clareo Health

COMPLETEDPHASE2

An Open-label Extension Study to Evaluate the Safety of the 13 mg Bimatoprost Ocular Insert

An Open-label Extension (OLE 2) Study to Evaluate the Safety of the 13 mg Bimatoprost Ocular Insert in Subjects With Open-angle Glaucoma or Ocular Hypertension Who Have Completed Study FSV5-004

NCT02537015•ForSight Vision5, Inc.

View on ClinicalTrials.gov

Summary

This study evaluated the long-term (9-months) safety of the Bimatoprost Ocular Insert in participants with Glaucoma or Ocular Hypertension who completed study FSV5-004. All the participants received Bimatoprost Ocular Insert and wore it for approximately 3 months (12 weeks), then had that Insert removed and a new Insert placed for another 26 weeks (approximately 6 months).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Completed FSV5-004 study.
•2. Written informed consent prior to any study procedure.
•3. Willingness to comply with the visit schedule.

Exclusion Criteria

•1. Participation in an investigational drug or device study other than FSV5-004 within the past 6 months or anticipated participation during the study period.
•2. Subjects who will require contact lens use during the study period.
•3. Any condition or situation (such as uncontrolled systemic disease) that, in the Investigator's opinion, might confound the results of the study, may put the subject at significant risk or might interfere with the subject's ability to participate in the study.

Locations (9)

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; Cornerstone Eye Care

High Point, North Carolina, United States

University 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

August 10, 2015

Primary Completion Date

August 11, 2016

Completion Date

August 11, 2016

Last Updated

April 2, 2019

Enrollment

ACTUAL participants

Conditions

Primary Open-Angle GlaucomaOcular Hypertension

Interventions

Bimatoprost

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: April 2, 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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An Open-label Extension Study to Evaluate the Safety of the 13 mg 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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