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

2026年6月16日 更新者：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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

600

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • California
      • Beverly Hills、California、美国、90210
        • 尚未招聘
        • National Clinical Trials
        • 接触：
        • 首席研究员：
          • James Khodabakhsh, Dr
      • Inglewood、California、美国、90301
        • 尚未招聘
        • United Medical Research Institute
        • 接触：
        • 首席研究员：
          • James H Peace, Dr
      • Newport Beach、California、美国、92663
        • 招聘中
        • Eye Research Foundation, Inc.
        • 接触：
        • 首席研究员：
          • David Wirta, Dr.
      • Newport Beach、California、美国、92663
      • Petaluma、California、美国、94954
        • 尚未招聘
        • North Bay Eye Associates
        • 接触：
        • 首席研究员：
          • Jason Bacharach, Dr
    • Florida
      • Boynton Beach、Florida、美国、33437
        • 尚未招聘
        • Advanced Research, LLC
        • 接触：
        • 首席研究员：
          • Sirtaz Sibia, Dr
      • Miami Beach、Florida、美国、33140
        • 尚未招聘
        • Quantum Clinical Trials
        • 接触：
        • 首席研究员：
          • Shani Reich, Dr
      • Weston、Florida、美国、33326
        • 尚未招聘
        • Advanced Research, LLC
        • 接触：
        • 首席研究员：
          • Aarub Kubal, Dr
    • Georgia
      • Morrow、Georgia、美国、30260
        • 尚未招聘
        • Clayton Eye Clinical Research
        • 接触：
        • 首席研究员：
          • Lauren Dubiner, Dr
      • Roswell、Georgia、美国、30076
        • 尚未招聘
        • Coastal Research Associates, LLC
        • 接触：
        • 首席研究员：
          • Douglas G Day, Dr
    • Kentucky
      • Louisville、Kentucky、美国、40206
    • Missouri
      • St Louis、Missouri、美国、63128
        • 尚未招聘
        • Tekwani Vision Center
        • 接触：
        • 首席研究员：
          • Navin Tekwani, Dr
      • St Louis、Missouri、美国、63131
        • 尚未招聘
        • Ophthalmology associate (Eye care)
        • 接触：
        • 首席研究员：
          • Rajan P Malhotra, Dr
    • New York
      • Rochester、New York、美国、14618
        • 尚未招聘
        • Rochester Ophthalmological Group
        • 接触：
        • 首席研究员：
          • Paul Hartman, Dr
    • Texas
      • Houston、Texas、美国、77008
        • 尚未招聘
        • Houston Eye Associates
        • 接触：
        • 首席研究员：
          • Kevin Y Jong, Dr
      • San Antonio、Texas、美国、78229
        • 尚未招聘
        • R and R eye research
        • 接触：
        • 首席研究员：
          • Anhtuan Nguyen, Dr

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：治疗方案
药品：Bimatoprost ophthalmic solution 0.01% YSBP
YSBP
有源比较器：Treatment R
药品：bimatoprost ophthalmic solution 0.01% (Lumigan®)
Lumigan®

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Intra-Ocular Pressure
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

YS Life Science Co., Ltd.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月2日

初级完成 (估计的)

2027年11月1日

研究完成 (估计的)

2027年12月31日

研究注册日期

首次提交

2026年6月16日

首先提交符合 QC 标准的

2026年6月16日

首次发布 (实际的)

2026年6月22日

研究记录更新

最后更新发布 (实际的)

2026年6月22日

上次提交的符合 QC 标准的更新

2026年6月16日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • YSLS001

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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