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

NCT ID: NCT02143843

Last Updated: 2019-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-05
• Study Completion Date: 2016-01-31

Brief Summary

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.

Conditions

Primary Open-Angle Glaucoma; Ocular Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

13 mg Bimatoprost Ocular Insert

13 mg Bimatoprost Ocular Insert used continuously for 7 months, then replaced with a new 13 mg Bimatoprost Ocular Insert and used continuously for another 6 months.

Group Type: EXPERIMENTAL

Bimatoprost

Intervention Type: DRUG

Bimatoprost Ocular Insert used continuously for 7 months, then replaced with a new Bimatoprost Ocular Insert and used continuously for another 6 months.

Interventions

Bimatoprost

Bimatoprost Ocular Insert used continuously for 7 months, then replaced with a new Bimatoprost Ocular Insert and used continuously for another 6 months.

Intervention Type: DRUG

Other Intervention Names

"Lumigan" is the branded name of bimatoprost in eye drop form

Eligibility Criteria

Inclusion Criteria

1. Completed FSV5-002 study.

2. Written informed consent prior to any study procedure.

3. Willingness to comply with the visit schedule.

Exclusion Criteria

1. Participation in an investigational drug or device study other than FSV5-002 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ForSight Vision5, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michelle Chen, PhD

Role: STUDY_DIRECTOR

Allergan

Locations

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

Countries

United States

References

Brandt JD, DuBiner HB, Benza R, Sall KN, Walker GA, Semba CP; Collaborators. Long-term Safety and Efficacy of a Sustained-Release Bimatoprost Ocular Ring. Ophthalmology. 2017 Oct;124(10):1565-1566. doi: 10.1016/j.ophtha.2017.04.022. Epub 2017 May 17. No abstract available.

Reference Type: DERIVED

PMID: 28528010 (View on PubMed)

Other Identifiers

FSV5-003

Identifier Type: -

Identifier Source: org_study_id