The Safety and Efficacy of SYD-101 in Children With Myopia

Study Overview
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Brief Summary
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Myopia, or nearsightedness, is the most common eye disorder, often affecting more than 40% of adults in Europe, Asia and the USA. Severe myopia is associated with an increased risk of developing other eye conditions such as glucoma, cataracts and retinal detachment, which may lead to blindness. Early treatment of myopia in children could help slow the condition and minimize the risk of complications later in life. This study investigates the use of SYD-101, an eye solution, in slowing-down the progression of myopia in children.

Detailed Description
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This will be a 5-arm, multicentered, randomized, double-masked, vehicle-controlled study conducted in 2 parts. Part 1 is the primary treatment period of 3 years, during which participants will receive 1 of 3 masked medications. Part 2 is the randomized withdrawal period of 1 year, during which participants originally receiving Vehicle will receive SYD-101, and participants originally receiving SYD-101 will receive either Vehicle or SYD-101.

Official Title
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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

Conditions
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Nearsightedness, Near Sightedness, Near-sightedness

Intervention / Treatment
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* Drug: SYD-101 Dose 1
* Drug: SYD-101 Dose 2
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Myopia of 0.5 D (diopters) to 6.00 D (inclusive) in both eyes. Astigmatism ≤1.50 D in both eyes. Anisometropia ≤1.00 D in both eyes. If myopia is ≥0.75 D, participant must be wearing single vision eyeglasses or soft, daily-wear, single-vision contact lenses that meet study investigator's criteria. BCVA (best-corrected visual acuity) Snellen equivalent of 20/32 or better. Exclusion Criteria: Participants with a history or current evidence of a medical condition predisposing them to degenerative myopia (e.g. Marfan syndrome, Stickler syndrome), or a condition that may affect visual function or development (e.g. diabetes mellitus, chromosome anomaly). Current use of a monoamine oxidase inhibitor. Evidence of any ocular inflammation or infection in either eye, including blepharitis, conjunctivitis, keratitis, and scleritis. Past, present or future plans to use orthokeratology (orthoK), rigid gas-permeable, bifocal, progressive-addition, multi-focal, or other lenses to reduce myopia progression; or the use of atropine, pirenzepine or other anti-muscarinic agent for myopia. History or evidence of ocular surgery or planned future ocular surgery in either eye. Other protocol-defined inclusion/exclusion criteria could apply.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1: SYD-101 Dose 1; Part 2: SYD-101 Dose 1<br>1 drop in each eye at bedtime. | Drug: SYD-101 Dose 1<br>* Sterile topical ophthalmic solution<br>* Other names: atropine sulfate;|
| Experimental: Part 1: SYD-101 Dose 1; Part 2: Vehicle<br>1 drop in each eye at bedtime. | Drug: SYD-101 Dose 1<br>* Sterile topical ophthalmic solution<br>* Other names: atropine sulfate;Drug: Vehicle<br>* Sterile topical ophthalmic solution without active ingredient<br>* Other names: Placebo;|
| Experimental: Part 1: SYD-101 Dose 2; Part 2: SYD-101 Dose 2<br>1 drop in each eye at bedtime. | Drug: SYD-101 Dose 2<br>* Sterile topical ophthalmic solution<br>* Other names: atropine sulfate;|
| Experimental: Part 1: SYD-101 Dose 2; Part 2: Vehicle<br>1 drop in each eye at bedtime. | Drug: SYD-101 Dose 2<br>* Sterile topical ophthalmic solution<br>* Other names: atropine sulfate;Drug: Vehicle<br>* Sterile topical ophthalmic solution without active ingredient<br>* Other names: Placebo;|
| Placebo Comparator: Part 1: Vehicle; Part 2: SYD-101 Dose 2<br>1 drop in each eye at bedtime. | Drug: SYD-101 Dose 2<br>* Sterile topical ophthalmic solution<br>* Other names: atropine sulfate;Drug: Vehicle<br>* Sterile topical ophthalmic solution without active ingredient<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myopic progression >0.75 D (diopters) | Proportion of participants with confirmed myopic progression >0.75 D (diopters), based on SE (spherical equivalent) as measured by cycloplegic autorefraction | Month 36 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean annual myopic progression | Mean annual progression rate of myopia measured in diopters: Spherical Equivalent (SE) as measured by cycloplegic autorefraction. | Month 36 | 
| Proportion of participants with annual myopia progression rate <=0.50 D/year | Mean annual progression rate of myopia | Through Month 36 | 
| Proportion of participants with annual myopia progression rate <=0.25 D/year | Mean annual progression rate of myopia | Through Month 36 | 
| Proportion of participants with annual myopia progression rate > 0.50 D/year | Mean annual progression rate of myopia | Month 36 | 
| Time to progression of myopia >0.75 D (diopters) | Progression of myopia measured as Spherical Equivalent (SE) via cycloplegic autorefraction. | Up to 36 months (from date of randomization until date myopia progresses >0.75 D) | 
| Mean change from baseline in axial length | Measured by cycloplegic biometry | Baseline to Month 36 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children, Myopia