An Open-label Extension Study to Evaluate the Safety of the 13 mg Bimatoprost Ocular Insert
OLE2
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
1 other identifier
interventional
81
1 country
9
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).
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 Aug 2015
Shorter than P25 for phase_2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 10, 2015
CompletedFirst Submitted
Initial submission to the registry
August 27, 2015
CompletedFirst Posted
Study publicly available on registry
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 11, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 11, 2016
CompletedResults Posted
Study results publicly available
February 26, 2019
CompletedApril 2, 2019
March 1, 2019
1 year
August 27, 2015
February 1, 2019
March 26, 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.
Baseline (Day 0, enrollment in this study) to end of study (Week 38)
Other Outcomes (5)
Change From Baseline in Intraocular Pressure (IOP)
Baseline (Day 0 in study FSV5-004) to Weeks 4, 8, 12, 24 and 38
Percentage of Participants by Subject-Reported Comfort Assessment Categories
Baseline (Day 0, enrollment in this study) Weeks 4, 8, 12, 24 and 38
Bimatoprost Ocular Insert Retention Duration
Baseline (Day 0, enrollment in this study) to the end of study (Week 38)
- +2 more other outcomes
Study Arms (1)
13 mg Bimatoprost Ocular Insert
EXPERIMENTAL13 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.
Interventions
Bimatoprost Ocular Insert in each eye used continuously for 12 weeks, then replaced with a new Bimatoprost Ocular Insert in each eye used continuously for another 26 weeks.
Eligibility Criteria
You may qualify if:
- Completed FSV5-004 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 FSV5-004 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 (9)
Vold Vision
Fayetteville, Arkansas, 72704, United States
Sall Medical Research Center
Artesia, California, 90701, United States
Eye Research Foundation
Newport Beach, California, 92663, United States
Clayton Eye Center
Morrow, Georgia, 30260, United States
Mundorf Eye Center
Charlotte, North Carolina, 28204, United States
Cornerstone Health Care; Cornerstone Eye Care
High Point, North Carolina, 27262, United States
University Eye Specialists
Maryville, Tennessee, 37803, United States
Total Eye Care
Memphis, Tennessee, 38119, United States
R&R Eye Research, LLC
San Antonio, Texas, 78229, United States
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
August 27, 2015
First Posted
September 1, 2015
Study Start
August 10, 2015
Primary Completion
August 11, 2016
Study Completion
August 11, 2016
Last Updated
April 2, 2019
Results First Posted
February 26, 2019
Record last verified: 2019-03