NCT07661329招募中3 期
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).
YS Life Science Co., Ltd.16 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2026年6月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 16
- 主要终点
- Intra-Ocular Pressure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •No history of addiction to any recreational drug or drug dependence or alcohol addiction
排除标准
- •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
研究组 & 干预措施
Treatment T
Experimental
干预措施: Bimatoprost ophthalmic solution 0.01% YSBP (Drug)
Treatment R
Active Comparator
干预措施: bimatoprost ophthalmic solution 0.01% (Lumigan®) (Drug)
结局指标
主要结局
Intra-Ocular Pressure
时间窗: 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)
次要结局
未报告次要终点
研究者
研究点 (16)
Loading locations...
相似试验
已完成
4 期
A Randomised Control Study To Compare The Efficacy Of Intravitreal Faricimab6.0 mg Versus Aflibercept 2.0 mg In Management of Treatment Naive Diabetic Macular Edema In Indian PopulationCTRI/2024/09/073550Army Hospital Research And Referral72
尚未招募
4 期
Clinical Evaluation of Lifitegrast Ophthalmic Solution 5.0% in Dry Eye Disease Using In Vivo Confocal MicroscopyDry EyeNCT07560735Toyos Clinic30
招募中
2 期
A Clinical Study Evaluating Licaminlimab for Dry Eye DiseaseDry Eye Disease (DED)NCT07548632Oculis160
招募中
不适用
To determine effifacy and safety of generic brinzolamide ophthalmic suspension compared with AZOPT ® in subjects with open-angle glaucoma or ocular hypertension.Open-angle glaucoma, (2) ICD-10 Condition: H578||Other specified disorders of eye and adnexa,CTRI/2024/07/071413Riconpharma LLC660
尚未招募
3 期
Efficacy and Safety of FID 123472 Ophthalmic Solution for Ocular Redness in AdultsOcular HyperemiaNCT07531043Alcon Research230