Long-term Safety and Efficacy Extension Trial of Bimatoprost SR

Phase 3

Active, not recruiting

• Conditions: Ocular Hypertension; Open-Angle Glaucoma
• Interventions: Drug: Bimatoprost SR; Other: Standard of Care

• Registration Number: NCT03891446
• Lead Sponsor: AbbVie

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-25
• Study First Submitted QC: 2019-03-25
• Study Start: 2019-03-27
• Study First Posted: 2019-03-27
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-26
• Last Update Posted: 2025-08-28
• Primary Completion: 2026-07
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 455

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lead-in study 192024-093 Stage 2	Bimatoprost SR	Participants who received 1 Bimatoprost administration due to sustained efficacy: Study eye (Eye that received Bimatoprost SR in the lead-in study): 1 additional administration of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart from the lead-in study administration. 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.
Lead-in study ARGOS	Bimatoprost SR	Study eye (Eye that received Bimatoprost SR first in the lead-in study): 1 additional administration of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart from the lead-in study administration. Treated Fellow eye (Eye that received Bimatoprost SR second in the lead-in study): 1 additional administration of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart from the lead-in study administration. 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.
Lead-in study 192024-091 or -092 or -095	Standard of Care	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.
Lead-in study 192024-093 Stage 1	Standard of Care	Participants who received 1, 2 or 3 administrations and participants in Stage 2 who received 1 Bimatoprost SR administration due to safety concern or received 2 administrations. 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.
Lead-in study 192024-093 Stage 2	Standard of Care	Participants who received 1 Bimatoprost administration due to sustained efficacy: Study eye (Eye that received Bimatoprost SR in the lead-in study): 1 additional administration of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart from the lead-in study administration. 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.
Lead-in study ARGOS	Standard of Care	Study eye (Eye that received Bimatoprost SR first in the lead-in study): 1 additional administration of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart from the lead-in study administration. Treated Fellow eye (Eye that received Bimatoprost SR second in the lead-in study): 1 additional administration of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart from the lead-in study administration. 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.

Primary Outcome Measures

Name	Time	Method
Duration of effect of Bimatoprost SR	Approximately 24 months	Retreatment or rescue administered for IOP lowering, determined by the investigator.
Number of patients experiencing a treatment emergent adverse event	Approximately 24 months	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.

Trial Locations

Locations (124)

Trinity Research Group /ID# 240190; 🇺🇸 Dothan, Alabama, United States

Arizona Eye Center - West Ray Road /ID# 240239; 🇺🇸 Chandler, Arizona, United States

Arizona Glaucoma Specialists /ID# 240212; 🇺🇸 Phoenix, Arizona, United States

M&M Eye Institute /ID# 240236; 🇺🇸 Prescott, Arizona, United States

Horizon Eye Specialists & Lasik Centers /ID# 240255; 🇺🇸 Sun City, Arizona, United States

Angeles Eye Institute /ID# 250397; 🇺🇸 Culver City, California, United States

Duplicate_Lakeside Vision Center /ID# 240204; 🇺🇸 Irvine, California, United States

Hamilton Glaucoma Center Shiley Eye Center UCSD /ID# 240196; 🇺🇸 La Jolla, California, United States

The Eye Research Foundation /ID# 240186; 🇺🇸 Newport Beach, California, United States

North Bay Eye Associates Inc. /ID# 248912; 🇺🇸 Petaluma, California, United States

Scroll for more (114 remaining)