The Safety and Efficacy of SYD-101 in Children With Myopia
STAR
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
1 other identifier
interventional
852
3 countries
47
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2019
Longer than P75 for phase_3
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2019
CompletedFirst Posted
Study publicly available on registry
April 18, 2019
CompletedStudy Start
First participant enrolled
April 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2025
CompletedJanuary 15, 2026
January 1, 2026
5 years
April 12, 2019
January 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Mean annual myopic progression
Month 36
Proportion of participants with annual myopia progression rate <=0.50 D/year
Through Month 36
Proportion of participants with annual myopia progression rate <=0.25 D/year
Through Month 36
Proportion of participants with annual myopia progression rate > 0.50 D/year
Month 36
Time to progression of myopia >0.75 D (diopters)
Up to 36 months (from date of randomization until date myopia progresses >0.75 D)
- +1 more secondary outcomes
Study Arms (3)
SYD-101 0.01%
EXPERIMENTAL1 drop in each eye at bedtime. Part 1: participants will be randomized to SYD-101 0.01% Part 2: participants will be re-randomized to SYD-101 0.01% or Vehicle
SYD-101 0.03%
EXPERIMENTAL1 drop in each eye at bedtime. Part 1: participants will be randomized to SYD-101 0.03% Part 2: participants will be re-randomized to SYD-101 0.03% or Vehicle
Vehicle
PLACEBO COMPARATOR1 drop in each eye at bedtime. Part 1: participants will be randomized to Vehicle Part 2: participants will be re-randomized to SYD-101 0.03%
Interventions
Sterile topical ophthalmic solution without active ingredient
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sydnexis, Inc.lead
Study Sites (47)
Site 143
Irwindale, California, 91706, United States
Site 144
Pasadena, California, 91105, United States
Site 148
San Diego, California, 92127, United States
Site 104
San Diego, California, 92131, United States
Site 110
Santa Barbara, California, 93110, United States
Site 133
Sunnyvale, California, 94087, United States
Site 130
Colorado Springs, Colorado, 80920, United States
Site 100
Fort Collins, Colorado, 80528, United States
Site 102
Danbury, Connecticut, 06810, United States
Site 150
Waterbury, Connecticut, 06708, United States
Site 122
Fort Lauderdale, Florida, 33309, United States
Site 109
Jupiter, Florida, 33477, United States
Site 119
Sweetwater, Florida, 33182, United States
Site 120
Tamarac, Florida, 33321, United States
Site 124
Marietta, Georgia, 30060, United States
Site 116
Chicago, Illinois, 60616, United States
Site 106
Wilmette, Illinois, 60091, United States
Site 135
Indianapolis, Indiana, 46202, United States
Site 131
Munster, Indiana, 46321, United States
Site 137
Pittsburg, Kansas, 66762, United States
Site 138
Bangor, Maine, 04401, United States
Site 123
Boston, Massachusetts, 02111, United States
Site 114
Washington, Missouri, 63090, United States
Site 132
Henderson, Nevada, 89052, United States
Site 139
Albuquerque, New Mexico, 87109, United States
Site 127
Buffalo, New York, 14209, United States
Site 117
Chapel Hill, North Carolina, 27517, United States
Site 121
Raleigh, North Carolina, 27603, United States
Site 105
Fargo, North Dakota, 58103, United States
Site 111
Medford, Oregon, 97504, United States
Site 147
Tigard, Oregon, 97223, United States
Sie 136
Bala-Cynwyd, Pennsylvania, 19004-1108, United States
Site 128
Cranberry Township, Pennsylvania, 16066, United States
Site 108
Charleston, South Carolina, 29425, United States
Site 126
Lakeway, Texas, 78734, United States
Site 142
San Antonio, Texas, 78215, United States
Site 101
San Antonio, Texas, 78240, United States
Site 115
The Woodlands, Texas, 77380, United States
Site 149
Ogden, Utah, 84403, United States
Site 140
Ogden, Utah, 84405, United States
Site 113
Virginia Beach, Virginia, 23452, United States
Site 204
Graz, Styria, 8036, Austria
Site 203
Linz, Upper Austria, 4021, Austria
Site 205
Vienna, 1140, Austria
Site 202
Bratislava, 833 40, Slovakia
Site 201
Trebišov, 075 01, Slovakia
Site 200
Trenčín, 91108, Slovakia
Related Publications (3)
Johnson P, Widder K, Cheetham J, Kirkeby L. Methods and baseline of a large, multicenter, phase 3 study with low-dose atropine (SYD-101) for the treatment of myopia progression in over 800 children (STAR Study). Invest Ophthalmol Vis Sci. 2025; 66(8), 2825
BACKGROUNDCheetham JK, Gieschen L, Kirkeby L, Widder K, Johnson P. The natural history of myopia progression in a large diverse pediatric population. Invest Ophthalmol Vis Sci. 2025; 66(8), 2824
BACKGROUNDKorenfeld M, Hurcikova M, Tatsuoka K, Tomcikova D, Cheetham J, Kacerik M; STAR Study Investigators. STudy of Atropine to Reduce (STAR) Myopia Progression in Children: 24-Month Results of a Randomized, Double-Masked, Vehicle-Controlled Trial of Atropine Sulfate 0.01% and 0.03. Ophthalmol Ther. 2026 Mar 23. doi: 10.1007/s40123-026-01341-0. Online ahead of print.
PMID: 41870844DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2019
First Posted
April 18, 2019
Study Start
April 24, 2019
Primary Completion
May 2, 2024
Study Completion
May 1, 2025
Last Updated
January 15, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share