An Open-label Extension Study to Evaluate the Safety of the 13 mg Bimatoprost Ocular Insert

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Primary Open-Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Bimatoprost


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 13 mg Bimatoprost Ocular Insert<br>13 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. | Drug: Bimatoprost<br>* 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.<br>* Other names: Lumigan is the branded name of bimatoprost in eye drop form;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |