RecruitingPhase 3NCT07661329

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

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).

Sponsor

YS Life Science Co., Ltd.

Enrollment

600 participants

Start Date

Jun 2, 2026

Study Type

INTERVENTIONAL

Conditions

Ocular Hypertension (OH)Primary Open Angle Glaucoma (POAG)

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Bimatoprost ophthalmic solution 0.01% YSBP and a drug called bimatoprost ophthalmic solution 0.01% (Lumigan®) for people with ocular hypertension (oh) and primary open angle glaucoma (poag). The study is currently recruiting participants at 16 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBimatoprost ophthalmic solution 0.01% YSBP

YSBP

DRUGbimatoprost 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07661329

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