2023-509134-19-00已完成3 期
A Multicenter, Randomized, Double-Masked, Vehicle-Controlled Study to Assess the Safety and Efficacy of SYD-101 Ophthalmic Solution for the Treatment of Myopia in Children
Sydnexis Inc., Sydnexis Inc.6 个研究点 分布在 2 个国家目标入组 70 人开始时间: 2024年4月18日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 6
- 主要终点
- Mean annual progression rate of myopia through month 24
研究概览
简要总结
To evaluate the efficacy of SYD-101 for slowing the progression of myopia in children To evaluate the safety and tolerability of SYD-101
研究设计
- 分配方式
- Randomized
- 主要目的
- Randomized withdrawal period
- 盲法
- Double (Investigator, Monitor, Analyst, Carer, Subject)
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Parent/guardian has the ability to understand the study informed consent form (ICF) and agrees to sign the ICF prior to initiation of any protocol-related procedures; participant has the ability to give assent, as applicable, at the time of parental/guardian consent
- •BCVA of 75 letters (Snellen equivalent 20/32) or better
- •Normal IOP <21 mmHg
- •Participant is male or female between 3 and 14 years of age (inclusive) at the time of Screening
- •Participant and parent/guardian are willing and able to comply with study instructions, study visits, and procedures
- •Participant (or parent/guardian) has demonstrated ability to administer artificial eyedrops at the Screening or Baseline visit
- •Participant is in good general health, with no clinically significant findings based on medical history and vital signs, as determined by the investigator at the time of Screening
- •Postmenarchal female participants must have negative urine pregnancy test results
- •Refractive error by cycloplegic autorefraction at the baseline visit: a) Myopia of 0.50 D to 6.00 D (inclusive) b) Astigmatism ≤1.50 D c) Anisometropia ≤1.00 D
- •If the baseline myopia (SE) is <0.75 D, participant must have a history of myopia progression of 0.50 D in the previous 6 to 12 months
- •If baseline myopia (SE) is ≥0.75 D, participant must be wearing refractive correction (single vision eyeglasses or soft, daily-wear, single-vision contact lenses) that meets the following criteria: a) Myopia (SE) corrected to within ±0.50 D of the investigator’s cycloplegic measurement of refractive error b) Cylinder power must be within ±0.50 D of the investigator’s standard refraction technique, which can be based on a cycloplegic or non-cycloplegic refraction c) Cylinder axis must be within ±5 degrees of the axis found on the investigator’s standard refraction when cylinder power is ≥1.00 D or within ±15 degrees when the cylinder power is <1.00 D
排除标准
- •Participant is a female who is pregnant, lactating, or intending to become pregnant within next 4 years
- •Use of any of the following (previously, currently, or plans to do so in the future): a) Orthokeratology (orthoK), rigid gas-permeable, bifocal, progressive-addition, multi-focal, or other lenses to reduce myopia progression b) Use of atropine, pirenzepine, or other anti-muscarinic agent for myopia
- •History or evidence of any ocular surgery or planned future ocular surgery in either eye
- •History or current evidence of ocular disease in the either eye that, in the opinion of the investigator, may confound assessment of visual acuity and/or refraction
- •Unwillingness or inability to comply with study requirements and restrictions, including but not limited to those specified in Section 5.3 (eg, required conversion from extended wear lenses to daily wear lenses, full-time use of contact lenses or spectacles)
- •Participant has a known allergy or hypersensitivity to atropine or any of the components of SYD-101
- •Participant has history or current evidence of a medical condition predisposing the participant to degenerative myopia (eg, Marfan syndrome, Stickler syndrome) or a condition that may affect visual function or development (eg, diabetes mellitus, chromosome anomaly)
- •One or more biological parents with a history of myopia ≥9.00 D
- •Current use of a monoamine oxidase inhibitor
- •History of, or currently receiving treatment for, any systemic infection or autoimmune disease considered serious by the investigator
- •Participation in an investigational drug or device study within 30 days prior to Screening
- •Evidence of any ocular inflammation or infection in either eye, including blepharitis, conjunctivitis, keratitis, and scleritis
- •History or evidence of the following in either eye: a) Retinopathy of prematurity b) Abnormal refractive anatomy (eg, keratoconus, lenticonus, spherophakia) c) Amblyopia, manifest strabismus, or nystagmus
结局指标
主要结局
Mean annual progression rate of myopia through month 24
Mean annual progression rate of myopia through month 24
Evaluation of AEs and SAEs
Evaluation of AEs and SAEs
次要结局
- Proportion of participants with myopic progression >0.75 D at or before Month 24
- Proportion of participants with annual myopia progression rate through Month 24 ≤0.50 D/year
- Proportion of participants with annual myopia progression rate through Month 24 ≤0.25 D/year
- Proportion of participants with increase of myopia of >0.50 D at or before Month 24
- Time to progression of myopia of >0.75 D through Month 24
- Mean annual progression rate using Month 24 data on Subgroup of participants with refractive history of progression ≥ 0.5D
- Mean annual progression rate using Month 24 data on Subgroup of participants with refractive history of progression ≥ 0.75D
- Mean change from baseline in axial length at Month 24 (at sites with the requisite equipment; at least 50% of participants)
- Mean change from baseline in SE at Month 48 (ie, 12 months after randomized withdrawal)
- Mean time spent on various activities will be solicited via questionnaire
- Proportion of agreement to QOL statements
- Changes from baseline in vital sign measurements
- Mean change from baseline in pupil diameter. Mean change from baseline in binocular accommodative amplitude . Changes from baseline in findings detected by best-corrected visual acuity (BCVA), biomicroscopy, intraocular pressure (IOP), and ophthalmoscopy. Changes from baseline in corneal endothelial cell count (selected sites only; approximately 25% of study participants).
- Tolerability to the masked study drug will be solicited via questionnaire
- Pregnancy test results (female participants of childbearing potential only)
研究者
Janet Cheetham
Scientific
Sydnexis Inc.
研究点 (6)
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