An Open-Label Extension Study to Evaluate the Safety of the ForSight VISION5 Product
An Open-Label Extension (OLE) Study to Evaluate the Safety of the ForSight VISION5 Product in Subjects With Open-Angle Glaucoma or Ocular Hypertension Who Have Completed Study FSV5-002
1 other identifier
interventional
75
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2014
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2014
CompletedFirst Posted
Study publicly available on registry
May 21, 2014
CompletedStudy Start
First participant enrolled
June 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2016
CompletedResults Posted
Study results publicly available
February 26, 2019
CompletedFebruary 26, 2019
January 1, 2019
1.6 years
May 18, 2014
February 1, 2019
February 1, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
13 months
Secondary Outcomes (1)
Change From Baseline in Mean Intraocular Pressure (IOP)
Baseline (Day 1) to Month 13
Study Arms (1)
13 mg Bimatoprost Ocular Insert
EXPERIMENTAL13 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.
Interventions
Bimatoprost Ocular Insert used continuously for 7 months, then replaced with a new Bimatoprost Ocular Insert and used continuously for another 6 months.
Eligibility Criteria
You may qualify if:
- Completed FSV5-002 study.
- Written informed consent prior to any study procedure.
- Willingness to comply with the visit schedule.
You may not qualify if:
- Participation in an investigational drug or device study other than FSV5-002 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Sall Medical Research Center
Artesia, California, 90701, United States
Scripps Clinic Torrey Pines
La Jolla, California, 92037, United States
Eye Research Foundation
Newport Beach, California, 92663, United States
UC Davis Dept of Ophthalmology & Vision Science
Sacramento, California, 95817, United States
Coastal Research Associates
Atlanta, Georgia, 30076, United States
Clayton Eye Center
Morrow, Georgia, 30260, United States
Ophthalmology Consultants
St Louis, Missouri, 63131, United States
UNC Kittner Eye Center
Chapel Hill, North Carolina, 27517, United States
Apex Eye
Madeira, Ohio, 45243, United States
Ophthalmology Associates PC
Fort Worth, Texas, 76102, United States
Related Publications (1)
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.
PMID: 28528010DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head,
- Organization
- Allergan, Inc
Study Officials
- STUDY DIRECTOR
Michelle Chen, PhD
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2014
First Posted
May 21, 2014
Study Start
June 5, 2014
Primary Completion
December 31, 2015
Study Completion
January 31, 2016
Last Updated
February 26, 2019
Results First Posted
February 26, 2019
Record last verified: 2019-01