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NCT03918915 · ClinicalTrials.gov registry record · Phase 3
The Safety and Efficacy of SYD-101 in Children With Myopia
A Phase 3 study of Nearsightedness, sponsored by Sydnexis.
- Completed
- Registry status
- Phase 3
- Development phase
- 852
- Enrollment target
- 20
- Study locations
NCT03918915: Completed Phase 3 study of Nearsightedness, sponsored by Sydnexis.
NCT03918915 is a Phase 3 study of Nearsightedness that has completed, run by Sydnexis. The registered enrollment target is 852 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03918915, a Phase 3 study of Nearsightedness, has completed, sponsored by Sydnexis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 852 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Proportion of participants with confirmed myopic progression \<-0.75 D (diopters), based on SE (spherical equivalent) as measured by cycloplegic autorefraction
Conditions Studied
Interventions
- DRUG Vehicle
- DRUG SYD-101 0.01%
- DRUG SYD-101 0.03%
Study Locations (20)
California
- Site 143 - Irwindale
- Site 144 - Pasadena
- Site 148 - San Diego
- Site 104 - San Diego
- Site 110 - Santa Barbara
- Site 133 - Sunnyvale
Florida
- Site 122 - Fort Lauderdale
- Site 109 - Jupiter
- Site 119 - Sweetwater
- Site 120 - Tamarac
Colorado
- Site 130 - Colorado Springs
- Site 100 - Fort Collins
Connecticut
- Site 102 - Danbury
- Site 150 - Waterbury
Illinois
- Site 116 - Chicago
- Site 106 - Wilmette
Indiana
- Site 135 - Indianapolis
- Site 131 - Munster
Georgia
- Site 124 - Marietta
Kansas
- Site 137 - Pittsburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 852 participants |
| Start Date | 2019-04-24 |
| Est. Completion | 2025-05-01 |
| Phase | Phase 3 |
What the finished NCT03918915 record still lists
NCT03918915 is an interventional study that assigns participants to a tested intervention. The registered 852 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% higher).
The record links to 1 condition, with Nearsightedness appearing as the primary indexed condition, and to 3 interventions - of which Vehicle is the first listed.
NCT03918915 names 20 study sites across 8 states, led by California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT03918915 about?
NCT03918915 is a clinical study titled "The Safety and Efficacy of SYD-101 in Children With Myopia". 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. Earl...
What is the current status of trial NCT03918915?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 852 participants. The study started on 2019-04-24. Estimated completion is 2025-05-01.
What conditions does trial NCT03918915 study?
This clinical trial studies the following conditions: Nearsightedness.
What interventions are being tested in trial NCT03918915?
The interventions under investigation include: Vehicle (DRUG), SYD-101 0.01% (DRUG), SYD-101 0.03% (DRUG).
Who is sponsoring clinical trial NCT03918915?
This trial is sponsored by Sydnexis, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03918915 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03918915's enrollment target sits among peer trials
852 385th of 2000 higher than 1,615 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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