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RECRUITING
NCT07661329
PHASE3

A Comparative, Randomized, Investigator-blind, Active-controlled, Parallel-group, Multicenter, Clinical Endpoint Study

Sponsor: YS Life Science Co., Ltd.

View on ClinicalTrials.gov

Summary

This study is to establish non-inferiority of a preservative free formulation of Bimatoprost ophthalmic solution 0.01% (YSBP) of YS Life Science Co., Ltd. compared to LUMIGAN® (bimatoprost ophthalmic solution) 0.01% of AbbVie INC in subjects with primary open angle glaucoma (POAG) or ocular hypertension.

Official title: A Comparative Randomized, Investigator-Blind, Active-Controlled, Parallel-Group, Multicenter, Clinical Endpoint Study to Evaluate Efficacy and Safety of Bimatoprost Ophthalmic Solution 0.01% (YSBP) of YS Life Science Co., Ltd. (YSLS) and Lumigan® (Bimatoprost Ophthalmic Solution) 0.01% of AbbVie INC, in the Treatment of Subjects With Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2026-06-02

Completion Date

2027-12-31

Last Updated

2026-06-22

Healthy Volunteers

No

Interventions

DRUG

Bimatoprost ophthalmic solution 0.01% YSBP

YSBP

DRUG

bimatoprost ophthalmic solution 0.01% (Lumigan®)

Lumigan®

Locations (16)

National Clinical Trials

Beverly Hills, California, United States

United medical research institute

Inglewood, California, United States

Eye research foundation, Inc.

Newport Beach, California, United States

Visionary Eye Research Institute

Newport Beach, California, United States

North Bay Eye Associates

Petaluma, California, United States

Advanced research, LLC

Boynton Beach, Florida, United States

Quantum clinical trials

Miami Beach, Florida, United States

Advanced research, LLC

Weston, Florida, United States

Clayton Eye Clinical Research

Morrow, Georgia, United States

Coastal Research Associates, LLC

Roswell, Georgia, United States

The eye care institute

Louisville, Kentucky, United States

Tekwani vision center

St Louis, Missouri, United States

Ophthalmology associate (Eye care)

St Louis, Missouri, United States

Rochester Ophthalmological Group

Rochester, New York, United States

Houston Eye Associates

Houston, Texas, United States

R and R eye research

San Antonio, Texas, United States