Long-term Safety and Efficacy Extension Trial of Bimatoprost SR

Study Overview
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Brief Summary
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This study will evaluate the long-term safety and efficacy of Bimatoprost Sustained Release (SR) in patients with open-angle glaucoma or ocular hypertension who completed 1 of the 4 Phase 3 Bimatoprost SR studies (192024-091, -092, -093, or -095) and received Bimatoprost SR or who received commercial DURYSTA (Bimatoprost SR) in the open-label Phase 4 ARGOS study (MED-MA-EYE-0648) and completed (or exited early from) the study.

Official Title
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An Extension Trial to Evaluate the Long-term Safety and Efficacy of Bimatoprost SR in Patients With Open Angle Glaucoma or Ocular Hypertension

Conditions
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Open-Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Bimatoprost SR
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who completed 1 of the 4 Bimatoprost SR Phase 3 studies (192024-091, -092, -093, or -095) and received Bimatoprost SR. Participants who completed (or exited early from) the open-label Phase 4 ARGOS study with no ongoing safety concerns, and received DURYSTA. Exclusion Criteria: Female participants who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception during the study. Concurrent or anticipated enrollment in another investigational drug or device study during the present study. Any condition which would preclude the participant's ability to comply with study requirements, including completion of the study. Participants who were randomized to receive timolol eye drops in the study eye (control group) during the Phase 3 Bimatoprost Studies 192024-091 and -092. For patients from the ARGOS lead-in study: history of prior incisional glaucoma surgeries and/or minimally invasive glaucoma surgical procedures in the study eye or treated fellow eye.

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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lead-in study 192024-091 or -092 or -095<br>Study eye (Eye that received Bimatoprost SR in the lead-in study): No treatment is administered. Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Fellow eye will receive only standard of care, based on the investigator's judgment. | Other: Standard of Care<br>* Standard of care treatment based on investigator's judgement.<br>|
| Experimental: Lead-in study 192024-093 Stage 1<br>Participants in Lead-in Study 192024-093 Stage 1 and participants in Stage 2 who received only 1 Bimatoprost administration due to safety concerns: Study eye (Eye that received Bimatoprost SR in the lead-in study): No treatment is administered. Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Fellow eye will receive only standard of care, based on the investigator's judgment. | Other: Standard of Care<br>* Standard of care treatment based on investigator's judgement.<br>|
| Experimental: Lead-in study 192024-093 Stage 2<br>Participants in Lead-in Study 192024-093 Stage 2 who received only 2 Bimatoprost administrations or 1 Bimatoprost administration due to sustained efficacy: Study eye (Eye that received Bimatoprost SR in the lead-in study): 2 additional administrations of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart. Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Fellow eye will receive only standard of care, based on the investigator's judgment. | Drug: Bimatoprost SR<br>* Intraocular implant<br>* Other names: DURYSTA;Other: Standard of Care<br>* Standard of care treatment based on investigator's judgement.<br>|
| Experimental: Lead-in study ARGOS<br>Study eye (Eye that received Bimatoprost SR first in the lead-in study): 2 additional administrations of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart. Treated Fellow eye (Eye that received Bimatoprost SR second in the lead-in study): 2 additional administrations of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart. Untreated Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Untreated fellow eye will receive only standard of care, based on the investigator's judgment. | Drug: Bimatoprost SR<br>* Intraocular implant<br>* Other names: DURYSTA;Other: Standard of Care<br>* Standard of care treatment based on investigator's judgement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of effect of Bimatoprost SR | Retreatment or rescue administered for IOP lowering, determined by the investigator. | Approximately 24 months | 
| Number of patients experiencing a treatment emergent adverse event | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. | Approximately 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DURYSTA, Open-Angle Glaucoma, Ocular Hypertension, Bimatoprost