Long-term Safety and Efficacy of Bimatoprost SR for Glaucoma
(Maia Trial)

Recruiting in Palo Alto (17 mi)

+268 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Allergan

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

This trial is for people who have high blood pressure in the eye, open-angle glaucoma, or ocular hypertension and were part of earlier Bimatoprost SR studies. They must not be pregnant, nursing, planning pregnancy without contraception, or unable to follow study requirements.

Inclusion Criteria

I completed a Phase 3 study for Bimatoprost SR and received the treatment.

I finished or left early from the ARGOS study without safety issues and received DURYSTA.

Exclusion Criteria

You cannot have been given timolol eye drops in your study eye during a previous phase 3 bimatoprost study.

Any condition which would preclude the participant's ability to comply with study requirements, including completion of the study.

Concurrent or anticipated enrollment in another investigational drug or device study during the present study.

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Treatment Details

Interventions

Bimatoprost SR (Prostaglandin Analog)

Trial OverviewThe long-term safety and effectiveness of Bimatoprost Sustained Release (SR) are being tested on patients with certain eye conditions who previously received this treatment during earlier phases of research.

Participant Groups

4Treatment groups

Experimental Treatment

Group I: Lead-in study ARGOSExperimental Treatment2 Interventions

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.

Group II: Lead-in study 192024-093 Stage 2Experimental Treatment2 Interventions

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.

Group III: Lead-in study 192024-093 Stage 1Experimental Treatment1 Intervention

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.

Group IV: Lead-in study 192024-091 or -092 or -095Experimental Treatment1 Intervention

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.