Phase 2
Completed N=81
An Open-label Extension Study to Evaluate the Safety of the 13 mg Bimatoprost Ocular Insert
Source: ClinicalTrials.gov NCT02537015 ↗Enrolled (actual)
81
Serious AEs
8.6%
Results posted
Feb 2019
Primary outcomePrimary: Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity — 25.9; 11.1; 0; 6.2 percentage of participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity |
25.9; 11.1; 0; 6.2; 8.6; 4.9 | — |
Eligibility Criteria
Inclusion Criteria
- Completed FSV5-004 study.
- Written informed consent prior to any study procedure.
- Willingness to comply with the visit schedule.
Key Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02537015). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.