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

Completed · Phase 2

Conditions studied: Primary Open-Angle Glaucoma, Ocular Hypertension

In brief

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.

Key facts

Study ID

NCT02143843

Run by

ForSight Vision5, Inc.

People needed

75

Starts

2014-06-05

Expected to finish

2016-01-31

Last updated by the study team

2019-02-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Completed FSV5-002 study.
• Written informed consent prior to any study procedure.
• Willingness to comply with the visit schedule.

You may not qualify if…

• Participation in an investigational drug or device study other than FSV5-002 within the past 6 months or anticipated participation during the study period.
• Subjects who will require contact lens use during the study period.
• 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.

Where it is running

• 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
• UC Davis Dept of Ophthalmology & Vision Science — Sacramento, California, United States
• Coastal Research Associates — Atlanta, Georgia, United States
• Clayton Eye Center — Morrow, Georgia, United States
• Ophthalmology Consultants — St Louis, Missouri, United States
• UNC Kittner Eye Center — Chapel Hill, North Carolina, United States
• Apex Eye — Madeira, Ohio, United States
• Ophthalmology Associates PC — Fort Worth, Texas, United States

Full record on ClinicalTrials.gov

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