Bimatoprost SR for Glaucoma

Recruiting in Palo Alto (17 mi)

+126 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 trial tests a long-lasting eye medication called Bimatoprost SR. It is for people with certain eye conditions who can't use regular eye drops effectively. The medication works by helping fluid drain from the eye, reducing pressure. Bimatoprost has been widely used for glaucoma management, typically delivered via eye drops, but newer methods like sustained-release implants are being explored to improve efficiency.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

This trial is for people with open-angle glaucoma or ocular hypertension who need treatment to lower their eye pressure but can't use topical medication effectively. Participants should not have used Bimatoprost SR before or been in another drug/device study within the last 2 months.

Inclusion Criteria

I have glaucoma or high eye pressure needing treatment.

Exclusion Criteria

Concurrent or anticipated enrollment in another investigational drug or device study or participation in such a study within 2 months prior to enrolling in this study.

I have received Bimatoprost SR treatment in my study eye before.

Treatment Details

Interventions

Bimatoprost (SR) (Prostaglandin Analog)

Trial OverviewThe study tests how long the effect of Bimatoprost sustained release (SR) lasts in lowering intraocular pressure and its safety when given as needed to patients with open-angle glaucoma or ocular hypertension.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Bimatoprost SR - Dose BExperimental Treatment1 Intervention

Study Eye: Participants received 1 - 3 Cycles of Bimatoprost SR administrations of Dose B Fellow Eye: The eye that does not receive Bimatoprost SR treatment will receive standard of care or up to one administration of Bimatoprost SR.

Group II: Bimatoprost SR - Dose AExperimental Treatment1 Intervention

Study Eye: Participants will receive 1 - 2 Cycles of Bimatoprost SR administrations of Dose A Fellow Eye: The eye that does not receive Bimatoprost SR treatment will receive standard of care or up to one administration of Bimatoprost SR.