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

ForSight Vision5, Inc.81 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Primary Open-Angle Glaucoma Ocular Hypertension

Interventions

BimatoprostDRUG

Bimatoprost Ocular Insert in each eye used continuously for 12 weeks, then replaced with a new Bimatoprost Ocular Insert in each eye used continuously for another 26 weeks.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

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

Outcomes

Primary Outcomes

Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity

An AE was defined as any untoward medical occurrence (eg, sign, symptom, disease, syndrome, intercurrent illness) that occurred in a study participant, regardless of the suspected cause during the study. An ocular AE is an AE that occurred in the eye and non-ocular is an AE that occurred not in the eye. The investigator assessed the worst severity of each AE as: Mild=aware of sign or symptom, but readily tolerated, Moderate=discomfort enough to cause interference with usual activity or Severe=incapacitating with inability to work or do usual activity.

Time frame: Baseline (Day 0, enrollment in this study) to end of study (Week 38)

Data from ClinicalTrials.gov

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