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A Study to Evaluate Efficacy and Safety of YSBP Compared to Lumigan in Patients With Glaucoma or Ocular Hypertension
Sponsor: YS Life Science Co., Ltd.
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
2026-09-23
Healthy Volunteers
No
Interventions
Bimatoprost ophthalmic solution 0.01% YSBP
YSBP
bimatoprost ophthalmic solution 0.01% (Lumigan®)
Lumigan®
Locations (22)
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
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
Houston Eye Associates
Houston, Texas, United States
R and R eye research
San Antonio, Texas, United States
Jyoti eye hospital
Ahmedabad, Gujarat, India
M&J western regional institute of ophthalmology
Ahmedabad, Gujarat, India
GMERS medical college and civil hospital sola
Ahmedabad, Gujarat, India
Netralaya super speciality eye care hospital
Ahmedabad, Gurajat, India
Ambade eye hospital
Nagpur, Maharashtra, India
Dr. D. Y. Patil medical college hospital & research centre
Nerul, Mumbai, India
LV Prasad eye institute
Bhubaneswar, Odisha, India
Regional institute of ophthalmology
Kolkata, West Bengal, India