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An Open-Label Extension Study to Evaluate the Safety of the ForSight VISION5 Product

NCT02143843 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2019-02-26

Study results available
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Summary

This study evaluates the long-term (13-months) safety of the Bimatoprost Ocular Insert in participants with Glaucoma or Ocular Hypertension who completed study FSV5-002. All participants received Bimatoprost Ocular Insert and wore it for approximately 7 months, then had the Insert removed and a new insert placed for another 6 months.

Conditions

Interventions

DRUG

Bimatoprost

Bimatoprost Ocular Insert used continuously for 7 months, then replaced with a new Bimatoprost Ocular Insert and used continuously for another 6 months.

Sponsors & Collaborators

  • ForSight Vision5, Inc.

    lead INDUSTRY

Principal Investigators

  • Michelle Chen, PhD · Allergan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-05
Primary Completion
2015-12-31
Completion
2016-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02143843 on ClinicalTrials.gov