Evaluation of the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension

Phase 3

Active, not recruiting

• Conditions: Open-Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: Bimatoprost (SR)

• Registration Number: NCT03850782
• Lead Sponsor: AbbVie

Brief Summary

This study evaluates the duration of intraocular pressure (IOP)-lowering effect and safety of as needed administrations of Bimatoprost sustained release (SR) in participants with open-angle glaucoma (OAG) or ocular hypertension (OHT) who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-11
• Study First Submitted QC: 2019-02-20
• Study First Posted: 2019-02-22
• Study Start: 2019-02-28
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-09
• Last Update Posted: 2024-02-13
• Primary Completion: 2025-08-09
• Study Completion: 2025-08-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 515

Inclusion Criteria

• Diagnosis of either open angle glaucoma (OAG) (i.e., primary OAG, pseudoexfoliation glaucoma, pigmentary glaucoma) or ocular hypertension requiring intraocular pressure-lowering 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.
• Previous administration with Bimatoprost SR in the study eye.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bimatoprost SR - Dose A	Bimatoprost (SR)	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.
Bimatoprost SR - Dose B	Bimatoprost (SR)	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.

Primary Outcome Measures

Name	Time	Method
Retreatment or rescue administered for IOP	Up to 48 months	Treatment modality determined by investigator.
Number of patients experiencing a treatment emergent adverse event	Baseline up to 48 months	The number of patients who experienced one or more TEAE during the 48 month treatment period.

Trial Locations

Locations (108)

Horizon Eye Specialists & Lasik Centers /ID# 235240; 🇺🇸 Sun City, Arizona, United States

Atlantis Eye Care /ID# 235530; 🇺🇸 Huntington Beach, California, United States

Lakeside Vision Center /ID# 234970; 🇺🇸 Irvine, California, United States

Global Research Foundation /ID# 237350; 🇺🇸 Los Angeles, California, United States

The Eye Research Foundation /ID# 234521; 🇺🇸 Newport Beach, California, United States

Byers Eye Institute Stanford /ID# 235544; 🇺🇸 Palo Alto, California, United States

Foothill Eye Institute /ID# 235640; 🇺🇸 Pasadena, California, United States

Connecticut Eye Consultants P.C. /ID# 234981; 🇺🇸 Danbury, Connecticut, United States

Specialty Retina Center /ID# 236045; 🇺🇸 Coral Springs, Florida, United States

Segal Drug Trials, Inc /ID# 235784; 🇺🇸 Delray Beach, Florida, United States

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