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

Overview

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.

Full Title of Study: “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”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Study Primary Completion Date: June 2024

Detailed Description

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.

Interventions

• Drug: SYD-101 Dose 1
  • Sterile topical ophthalmic solution
• Drug: SYD-101 Dose 2
  • Sterile topical ophthalmic solution
• Drug: Vehicle
  • Sterile topical ophthalmic solution without active ingredient

Arms, Groups and Cohorts

• Experimental: Part 1: SYD-101 Dose 1; Part 2: SYD-101 Dose 1
  • 1 drop in each eye at bedtime.
• Experimental: Part 1: SYD-101 Dose 1; Part 2: Vehicle
  • 1 drop in each eye at bedtime.
• Experimental: Part 1: SYD-101 Dose 2; Part 2: SYD-101 Dose 2
  • 1 drop in each eye at bedtime.
• Experimental: Part 1: SYD-101 Dose 2; Part 2: Vehicle
  • 1 drop in each eye at bedtime.
• Placebo Comparator: Part 1: Vehicle; Part 2: SYD-101 Dose 2
  • 1 drop in each eye at bedtime.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

• Mean annual myopic progression
  • Time Frame: Month 36
  • Mean annual progression rate of myopia measured in diopters: Spherical Equivalent (SE) as measured by cycloplegic autorefraction.
• Time to progression of myopia >0.75 D (diopters)
  • Time Frame: Up to 36 months (from date of randomization until date myopia progresses >0.75 D)
  • Progression of myopia measured as Spherical Equivalent (SE) via cycloplegic autorefraction.
• Mean change in axial length
  • Time Frame: Baseline to Month 36
  • Measured by cycloplegic biometry

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 3 Years

Maximum Age: 14 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Sydnexis, Inc.
• Provider of Information About this Clinical Study
  • Sponsor