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

NCT03918915 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 852

Last updated 2026-01-15

No results posted yet for this study

Summary

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.

Conditions

  • Nearsightedness
  • Near Sightedness
  • Near-sightedness

Interventions

DRUG

SYD-101 0.01%

Sterile topical ophthalmic solution

DRUG

SYD-101 0.03%

Sterile topical ophthalmic solution

DRUG

Vehicle

Sterile topical ophthalmic solution without active ingredient

Sponsors & Collaborators

  • Sydnexis, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-24
Primary Completion
2024-05-02
Completion
2025-05-01
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Slovakia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03918915 on ClinicalTrials.gov