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

Completed · Phase 2

Conditions studied: Primary Open-Angle Glaucoma, Ocular Hypertension

In brief

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).

Key facts

Study ID

NCT02537015

Run by

ForSight Vision5, Inc.

People needed

81

Starts

2015-08-10

Expected to finish

2016-08-11

Last updated by the study team

2019-04-02

Who can join

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

You may qualify if…

• Completed FSV5-004 study.
• Written informed consent prior to any study procedure.
• Willingness to comply with the visit schedule.
• Key Exclusion Criteria:
• Participation in an investigational drug or device study other than FSV5-004 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

• 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

Full record on ClinicalTrials.gov

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