Clinical trial NCT02143843: An Open-Label Extension Study to Evaluate the Safety of the ForSight VISION5 Product
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Open-Angle Glaucoma
Ocular Hypertension
Lead sponsor: ForSight Vision5, Inc.
Sponsor class: INDUSTRY
First posted: 2014-05-21
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity
timeFrame: 13 months
Secondary outcomes:
measure: Change From Baseline in Mean Intraocular Pressure (IOP)
timeFrame: Baseline (Day 1) to Month 13
Other outcomes:
Locations:
city: Artesia
country: United States
facility: Sall Medical Research Center
state: California
city: La Jolla
country: United States
facility: Scripps Clinic Torrey Pines
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Sacramento
country: United States
facility: UC Davis Dept of Ophthalmology & Vision Science
state: California
city: Atlanta
country: United States
facility: Coastal Research Associates
state: Georgia
city: Morrow
country: United States
facility: Clayton Eye Center
state: Georgia
city: Saint Louis
country: United States
facility: Ophthalmology Consultants
state: Missouri
city: Chapel Hill
country: United States
facility: UNC Kittner Eye Center
state: North Carolina
city: Madeira
country: United States
facility: Apex Eye
state: Ohio
city: Fort Worth
country: United States
facility: Ophthalmology Associates PC
state: Texas
Study officials:
affiliation: Allergan
name: Michelle Chen, PhD
role: STUDY_DIRECTOR
References:
citation: 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.