The Safety and Efficacy of SYD-101 in Children With Myopia
NCT ID: NCT03918915
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
852 participants
INTERVENTIONAL
2019-04-24
2025-05-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SYD-101 0.01%
1 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 0.01%
Sterile topical ophthalmic solution
SYD-101 0.03%
1 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
SYD-101 0.03%
Sterile topical ophthalmic solution
Vehicle
1 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%
Vehicle
Sterile topical ophthalmic solution without active ingredient
Interventions
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SYD-101 0.01%
Sterile topical ophthalmic solution
SYD-101 0.03%
Sterile topical ophthalmic solution
Vehicle
Sterile topical ophthalmic solution without active ingredient
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
3 Years
14 Years
ALL
No
Sponsors
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Sydnexis, Inc.
INDUSTRY
Responsible Party
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Locations
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Site 143
Irwindale, California, United States
Site 144
Pasadena, California, United States
Site 148
San Diego, California, United States
Site 104
San Diego, California, United States
Site 110
Santa Barbara, California, United States
Site 133
Sunnyvale, California, United States
Site 130
Colorado Springs, Colorado, United States
Site 100
Fort Collins, Colorado, United States
Site 102
Danbury, Connecticut, United States
Site 150
Waterbury, Connecticut, United States
Site 122
Fort Lauderdale, Florida, United States
Site 109
Jupiter, Florida, United States
Site 119
Sweetwater, Florida, United States
Site 120
Tamarac, Florida, United States
Site 124
Marietta, Georgia, United States
Site 116
Chicago, Illinois, United States
Site 106
Wilmette, Illinois, United States
Site 135
Indianapolis, Indiana, United States
Site 131
Munster, Indiana, United States
Site 137
Pittsburg, Kansas, United States
Site 138
Bangor, Maine, United States
Site 123
Boston, Massachusetts, United States
Site 114
Washington, Missouri, United States
Site 132
Henderson, Nevada, United States
Site 139
Albuquerque, New Mexico, United States
Site 127
Buffalo, New York, United States
Site 117
Chapel Hill, North Carolina, United States
Site 121
Raleigh, North Carolina, United States
Site 105
Fargo, North Dakota, United States
Site 111
Medford, Oregon, United States
Site 147
Tigard, Oregon, United States
Sie 136
Bala-Cynwyd, Pennsylvania, United States
Site 128
Cranberry Township, Pennsylvania, United States
Site 108
Charleston, South Carolina, United States
Site 126
Lakeway, Texas, United States
Site 142
San Antonio, Texas, United States
Site 101
San Antonio, Texas, United States
Site 115
The Woodlands, Texas, United States
Site 149
Ogden, Utah, United States
Site 140
Ogden, Utah, United States
Site 113
Virginia Beach, Virginia, United States
Site 204
Graz, Styria, Austria
Site 203
Linz, Upper Austria, Austria
Site 205
Vienna, , Austria
Site 202
Bratislava, , Slovakia
Site 201
Trebišov, , Slovakia
Site 200
Trenčín, , Slovakia
Countries
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References
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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
Cheetham 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
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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SYD-101-001
Identifier Type: -
Identifier Source: org_study_id
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