CTRI/2026/02/102870招募中4 期
A Multicentric, Open-label, Prospective, Non-comparative, Phase IV Clinical Study to Evaluate the Safety, Tolerability and Efficacy of Atropine Sulfate Ophthalmic Solution USP 0.05 percentage w/v for Controlling Progression of Myopia in Children.
Entod Pharmaceuticals Ltd.10 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2026年2月19日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 206
- 试验地点
- 10
研究概览
简要总结
A Multicentric, Open-label, Prospective, Non-comparative, Phase IV Clinical Study to Evaluate the Safety, Tolerability and Efficacy of Atropine Sulfate Ophthalmic Solution USP 0.05 percentage w/v for Controlling Progression of Myopia in Children.
Primary Objective:
To evaluate the safety and tolerability of Atropine Sulfate Ophthalmic Solution USP 0.05 percentage w/v for Controlling Progression of Myopia in Children.
Secondary Objective:
To evaluate the efficacy of Atropine Sulfate Ophthalmic Solution USP 0.05 percentage w/v for Controlling Progression of Myopia in Children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female child participants of age between Six to Fifteen years (both inclusive).
- •Participants with normal ocular health other than myopia.
- •Participants with refractive error of spherical equivalent (SE) range of minus 0.50 D to minus 6.00 D in both eyes.
- •Participants with Best-corrected distance visual acuity BCDVA 0.20 log MAR or better in both eyes.
- •The Investigator believes that the participant and participant’s parent or Legally Acceptable Representative LAR will comply with the requirements of the protocol.
- •Written assent informed parental consent obtained from the participant and parent/LAR of the participant for participation in the study.
排除标准
- •Participants with a known history of hypersensitivity to the study medications or any of the ingredients of the formulation.
- •Current or previous myopia treatment with non-study atropine, pirenzepine or other topical anti-muscarinic agents.
- •Participants with astigmatism of more than minus 1.5 D in either eye measured by cycloplegic autorefraction.
- •Participants with abnormality of the cornea, lens, central retina, iris or ciliary body.
- •Participants with current or prior history of ocular diseases (e.g., cataract, congenital retinal diseases, amblyopia, and strabismus).
- •Medical conditions predisposing participant to degenerative myopia, abnormal ocular refractive anatomy, and/or history of any other ocular diseases or ocular surgery.
- •Presence of a severe/serious ocular condition or any other unstable medical condition that, in the Investigators opinion, may preclude study treatment or follow-up.
- •Participants with clinically relevant current or past history of severe, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal and neurological diseases or any congenital conditions.
- •Suspected inability or unwillingness to comply with the protocol or other study procedures.
- •Participants currently participating in any other clinical trial or has participated in any other clinical trial thirty days prior to screening.
研究者
Dr Rohit Saxena
Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences
研究点 (10)
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