Clinical trial NCT02537015: An Open-label Extension Study to Evaluate the Safety of the 13 mg Bimatoprost Ocular Insert
Official title: An Open-label Extension (OLE 2) Study to Evaluate the Safety of the 13 mg Bimatoprost Ocular Insert in Subjects With Open-angle Glaucoma or Ocular Hypertension Who Have Completed Study FSV5-004
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: 2015-09-01
Enrollment: 81
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 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity
timeFrame: Baseline (Day 0, enrollment in this study) to end of study (Week 38)
Secondary outcomes:
Other outcomes:
measure: Change From Baseline in Intraocular Pressure (IOP)
timeFrame: Baseline (Day 0 in study FSV5-004) to Weeks 4, 8, 12, 24 and 38
measure: Percentage of Participants by Subject-Reported Comfort Assessment Categories
timeFrame: Baseline (Day 0, enrollment in this study) Weeks 4, 8, 12, 24 and 38
measure: Bimatoprost Ocular Insert Retention Duration
timeFrame: Baseline (Day 0, enrollment in this study) to the end of study (Week 38)
measure: Percentage of Participants Who Received Rescue Treatment
timeFrame: Baseline (Day 0, enrollment in this study) to the end of study (Week 38)
measure: Change From Baseline in Endothelial Cell Count
timeFrame: Baseline (Day 0, enrollment in this study) to end of study (Week 38)
Locations:
city: Fayetteville
country: United States
facility: Vold Vision
state: Arkansas
city: Artesia
country: United States
facility: Sall Medical Research Center
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Morrow
country: United States
facility: Clayton Eye Center
state: Georgia
city: Charlotte
country: United States
facility: Mundorf Eye Center
state: North Carolina
city: High Point
country: United States
facility: Cornerstone Health Care; Cornerstone Eye Care
state: North Carolina
city: Maryville
country: United States
facility: University Eye Specialists
state: Tennessee
city: Memphis
country: United States
facility: Total Eye Care
state: Tennessee
city: San Antonio
country: United States
facility: R&R Eye Research, LLC
state: Texas
Study officials:
affiliation: Allergan
name: Michelle Chen, PhD
role: STUDY_DIRECTOR
References: