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

June 16, 2026 updated by: YS Life Science Co., Ltd.

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).

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States, 90210
        • Not yet recruiting
        • National Clinical Trials
        • Contact:
        • Principal Investigator:
          • James Khodabakhsh, Dr
      • Inglewood, California, United States, 90301
        • Not yet recruiting
        • United medical research institute
        • Contact:
        • Principal Investigator:
          • James H Peace, Dr
      • Newport Beach, California, United States, 92663
        • Recruiting
        • Eye research foundation, Inc.
        • Contact:
        • Principal Investigator:
          • David Wirta, Dr.
      • Newport Beach, California, United States, 92663
      • Petaluma, California, United States, 94954
        • Not yet recruiting
        • North Bay Eye Associates
        • Contact:
        • Principal Investigator:
          • Jason Bacharach, Dr
    • Florida
      • Boynton Beach, Florida, United States, 33437
        • Not yet recruiting
        • Advanced Research, LLC
        • Contact:
        • Principal Investigator:
          • Sirtaz Sibia, Dr
      • Miami Beach, Florida, United States, 33140
        • Not yet recruiting
        • Quantum clinical trials
        • Contact:
        • Principal Investigator:
          • Shani Reich, Dr
      • Weston, Florida, United States, 33326
        • Not yet recruiting
        • Advanced Research, LLC
        • Contact:
        • Principal Investigator:
          • Aarub Kubal, Dr
    • Georgia
      • Morrow, Georgia, United States, 30260
        • Not yet recruiting
        • Clayton Eye Clinical Research
        • Contact:
        • Principal Investigator:
          • Lauren Dubiner, Dr
      • Roswell, Georgia, United States, 30076
        • Not yet recruiting
        • Coastal Research Associates, LLC
        • Contact:
        • Principal Investigator:
          • Douglas G Day, Dr
    • Kentucky
      • Louisville, Kentucky, United States, 40206
        • Not yet recruiting
        • The eye care institute
        • Contact:
        • Principal Investigator:
          • Brennan P Greene, Dr
    • Missouri
      • St Louis, Missouri, United States, 63128
        • Not yet recruiting
        • Tekwani vision center
        • Contact:
        • Principal Investigator:
          • Navin Tekwani, Dr
      • St Louis, Missouri, United States, 63131
        • Not yet recruiting
        • Ophthalmology associate (Eye care)
        • Contact:
        • Principal Investigator:
          • Rajan P Malhotra, Dr
    • New York
      • Rochester, New York, United States, 14618
        • Not yet recruiting
        • Rochester Ophthalmological Group
        • Contact:
        • Principal Investigator:
          • Paul Hartman, Dr
    • Texas
      • Houston, Texas, United States, 77008
        • Not yet recruiting
        • Houston Eye Associates
        • Contact:
        • Principal Investigator:
          • Kevin Y Jong, Dr
      • San Antonio, Texas, United States, 78229
        • Not yet recruiting
        • R and R eye research
        • Contact:
        • Principal Investigator:
          • Anhtuan Nguyen, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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:

    1. 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.
    2. Intrauterine device (IUD) or intrauterine system (IUS)
    3. Double barrier method of contraception (condom and occlusive cap or condom and spermicidal agent)
    4. Male sterilization (at least 6 months prior to screening, should be the sole male partner for that subject)
    5. Female sterilization (surgical bilateral oophorectomy) or tubal ligation at least 6 weeks prior to study participation
    6. Total abstinence; partial abstinence is not acceptable
  • No history of addiction to any recreational drug or drug dependence or alcohol addiction

Exclusion Criteria:

  • 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 or history within 3 months prior to baseline of any other significant ocular disease, e.g., corneal edema, uveitis, ocular infection, or ocular trauma in either eye (Note: stable myopia, strabismus, and cataracts will be allowed provided that the other inclusion/exclusion criteria are met).
  • 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.
  • Significant ocular surface findings (e.g., hyperemia or irritation, mild or greater) in either eye found on gross macroscopic or slit lamp examination.
  • Severe glaucoma with a cup/disk ratio greater than 0.8 (not including physiological cupping in the Investigators' opinion).
  • Chronic use of any systemic medication that may affect IOP with less than 2 months stable dosing regimen (i.e., sympathomimetic agents, betaadrenergic blocking agents, alpha-agonists, alpha-adrenergic blocking agents, calcium channel blockers, angiotensin-converting enzyme inhibitors, etc.)
  • Central Corneal thickness (CCT) <480 microns or >620 microns for study eye.
  • Known history or presence of any uncontrolled systemic disease
  • History of recurrent ocular seasonal allergies within past 2 years prior to screening.
  • Any other medical condition or serious intercurrent illness that, in the Investigator's opinion, may make it undesirable for the subject to participate in the study and would limit adherence to the study requirements.
  • Participation in any clinical study within 30 days before the first dose of the study drug.
  • Subjects with known cases of active Hepatitis B virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) infection.
  • Subjects with aphakia or history of herpes simplex keratitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment T
Drug: Bimatoprost ophthalmic solution 0.01% YSBP
YSBP
Active Comparator: Treatment R
Drug: bimatoprost ophthalmic solution 0.01% (Lumigan®)
Lumigan®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra-Ocular Pressure
Time Frame: Week 12
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

YS Life Science Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

June 16, 2026

First Submitted That Met QC Criteria

June 16, 2026

First Posted (Actual)

June 22, 2026

Study Record Updates

Last Update Posted (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 16, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YSLS001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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