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

Phase 2

Completed

• Conditions: Primary Open-Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: Bimatoprost

• Registration Number: NCT02537015
• Lead Sponsor: ForSight Vision5, Inc.

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-10
• Study First Submitted: 2015-08-27
• Study First Submitted QC: 2015-08-28
• Study First Posted: 2015-09-01
• Primary Completion: 2016-08-11
• Study Completion: 2016-08-11
• Disposition First Submitted: 2017-02-14
• Disposition First Submitted QC: 2017-02-14
• Disposition First Posted: 2017-02-15
• Results First Submitted: 2019-02-01
• Results First Submitted QC: 2019-02-01
• Results First Posted: 2019-02-26
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-26
• Last Update Posted: 2019-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
13 mg Bimatoprost Ocular Insert	Bimatoprost	13 mg Bimatoprost Ocular Insert in each eye used continuously for 12 weeks, then replaced with a new 13 mg Bimatoprost Ocular Insert in each eye used continuously for another 26 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity	Baseline (Day 0, enrollment in this study) to end of study (Week 38)	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.

Trial Locations

Locations (9)

Sall Medical Research Center; 🇺🇸 Artesia, California, United States

Total Eye Care; 🇺🇸 Memphis, Tennessee, United States

Eye Research Foundation; 🇺🇸 Newport Beach, California, United States

Clayton Eye Center; 🇺🇸 Morrow, Georgia, United States

Cornerstone Health Care; Cornerstone Eye Care; 🇺🇸 High Point, North Carolina, United States

R&R Eye Research, LLC; 🇺🇸 San Antonio, Texas, United States

University Eye Specialists; 🇺🇸 Maryville, Tennessee, United States

Vold Vision; 🇺🇸 Fayetteville, Arkansas, United States

Mundorf Eye Center; 🇺🇸 Charlotte, North Carolina, United States