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

NCT07661329 | Recruiting Phase 3 FDA Drug

• 1 other identifier: YSLS001
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Intra-Ocular Pressure

  the two sided 95% confidence interval (CI) for the treatment difference (test minus reference) in mean IOP of study eye (a continuous variable)

  Week 12

Study Arms (2)

Treatment T

EXPERIMENTAL

Drug: Bimatoprost ophthalmic solution 0.01% YSBP

Treatment R

ACTIVE COMPARATOR

Drug: bimatoprost ophthalmic solution 0.01% (Lumigan®)

Interventions

Bimatoprost ophthalmic solution 0.01% YSBP DRUG

YSBP

Treatment T

bimatoprost ophthalmic solution 0.01% (Lumigan®) DRUG

Lumigan®

Treatment R

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects willing and able to provide voluntary informed consent and to follow protocol requirements.
• Male or females aged ≥18 years.
• Subjects with primary open-angle glaucoma (POAG) or ocular hypertension (OH) in both eyes
• Subjects requiring treatment in both the eyes and able to discontinue the use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period.
• Adequate washout period prior to baseline (Day 0) of any ocular hypotensive medications
• Baseline (Day 0/hour 0) IOP ≥22 mm Hg and ≤ 34 mm Hg in both eyes, with difference between the IOP in left and right eyes not being more than 5 mm Hg
• Subjects' IOP is likely to be controlled with monotherapy.
• Baseline best corrected visual acuity equivalent to Snellen acuity of 20/100 or better in each eye, using a logarithmic visual acuity chart.
• Women of childbearing potential (defined as women physiologically capable of becoming pregnant unless they are using an effective method of contraception during the study participation) practicing any of the following acceptable methods of contraception:
• Oral or parenteral (injection, patch, or implant) hormonal contraception which has been continuously used for at least 1 month prior to first dose of study medication.
• Intrauterine device (IUD) or intrauterine system (IUS)
• Double barrier method of contraception (condom and occlusive cap or condom and spermicidal agent)
• Male sterilization (at least 6 months prior to screening, should be the sole male partner for that subject)
• Female sterilization (surgical bilateral oophorectomy) or tubal ligation at least 6 weeks prior to study participation
• Total abstinence; partial abstinence is not acceptable

You may not qualify if:

• Female subjects with positive pregnancy test or lactating or planning a pregnancy.
• Contraindication or known hypersensitivity to Bimatoprost, related class of drugs, or any of the excipients of formulation or benzalkonium chloride.
• Current or history of severe hepatic or renal impairment.
• Current corneal abnormalities that would prevent accurate IOP readings with tonometer.
• Functionally significant visual field loss as determined by perimetry.
• Subjects with corneal grafts.
• Subject has contraindication to pupil dilation.
• Use at any time prior to baseline of an intraocular corticosteroid implant.
• Use of contact lens within 1 week prior to baseline.
• Use within 21 days prior to baseline of 1) a topical ophthalmic corticosteroid or 2) a topical corticosteroid.
• Use within 21 days prior to baseline of a systemic corticosteroid.
• Use within 6 months prior to baseline of intravitreal or subtenon injection of an ophthalmic corticosteroid.
• Underwent within 3 months prior to baseline any other intraocular surgery (e.g., cataract surgery).
• Underwent any filtering surgery, or laser surgery for IOP reduction (e.g., laser trabeculoplasty) within 3 months prior to baseline or refractive surgery at any time.
• Subjects with a history of non-responder to bimatoprost monotherapy.

Sponsors & Collaborators

• YS Life Science Co., Ltd.: lead

Study Sites (16)

National Clinical Trials

Beverly Hills, California, 90210, United States

NOT YET RECRUITING

United medical research institute

Inglewood, California, 90301, United States

NOT YET RECRUITING

Eye research foundation, Inc.

Newport Beach, California, 92663, United States

RECRUITING

Visionary Eye Research Institute

Newport Beach, California, 92663, United States

NOT YET RECRUITING

North Bay Eye Associates

Petaluma, California, 94954, United States

NOT YET RECRUITING

Advanced research, LLC

Boynton Beach, Florida, 33437, United States

NOT YET RECRUITING

Quantum clinical trials

Miami Beach, Florida, 33140, United States

NOT YET RECRUITING

Advanced research, LLC

Weston, Florida, 33326, United States

NOT YET RECRUITING

Clayton Eye Clinical Research

Morrow, Georgia, 30260, United States

NOT YET RECRUITING

Coastal Research Associates, LLC

Roswell, Georgia, 30076, United States

NOT YET RECRUITING

The eye care institute

Louisville, Kentucky, 40206, United States

NOT YET RECRUITING

Tekwani vision center

St Louis, Missouri, 63128, United States

NOT YET RECRUITING

Ophthalmology associate (Eye care)

St Louis, Missouri, 63131, United States

NOT YET RECRUITING

Rochester Ophthalmological Group

Rochester, New York, 14618, United States

NOT YET RECRUITING

Houston Eye Associates

Houston, Texas, 77008, United States

NOT YET RECRUITING

R and R eye research

San Antonio, Texas, 78229, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Bimatoprost

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 22, 2026
• Study Start: June 2, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 22, 2026

Record last verified: 2026-06

Locations

US (16)