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

Status:	Completed
Conditions:	High Blood Pressure (Hypertension), Ocular
Therapuetic Areas:	Cardiology / Vascular Diseases, Ophthalmology
Healthy:	No
Age Range:	18 - Any
Updated:	4/4/2019
Start Date:	August 10, 2015
End Date:	August 11, 2016

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

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).

Inclusion Criteria:

1. Completed FSV5-004 study.

2. Written informed consent prior to any study procedure.

3. Willingness to comply with the visit schedule.

Key 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.

We found this trial at

sites

University Eye Specialists

Maryville, Tennessee 37803

from

Maryville, TN