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

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.

Study Overview

• Status: Completed
• Conditions: Nearsightedness; Near Sightedness; Near-sightedness
• Intervention / Treatment: Drug: Vehicle; Drug: SYD-101 0.01%; Drug: SYD-101 0.03%

Detailed Description

This will be a 3-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.

• Study Type: Interventional
• Enrollment (Actual): 852
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1140
    • Site 205
  • Styria
    • Graz, Styria, Austria, 8036
      • Site 204
  • Upper Austria
    • Linz, Upper Austria, Austria, 4021
      • Site 203
• Slovakia
  • Bratislava, Slovakia, 833 40
    • Site 202
  • Trebišov, Slovakia, 075 01
    • Site 201
  • Trenčín, Slovakia, 91108
    • Site 200
• United States
  • California
    • Irwindale, California, United States, 91706
      • Site 143
    • Pasadena, California, United States, 91105
      • Site 144
    • San Diego, California, United States, 92127
      • Site 148
    • San Diego, California, United States, 92131
      • Site 104
    • Santa Barbara, California, United States, 93110
      • Site 110
    • Sunnyvale, California, United States, 94087
      • Site 133
  • Colorado
    • Colorado Springs, Colorado, United States, 80920
      • Site 130
    • Fort Collins, Colorado, United States, 80528
      • Site 100
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Site 102
    • Waterbury, Connecticut, United States, 06708
      • Site 150
  • Florida
    • Fort Lauderdale, Florida, United States, 33309
      • Site 122
    • Jupiter, Florida, United States, 33477
      • Site 109
    • Sweetwater, Florida, United States, 33182
      • Site 119
    • Tamarac, Florida, United States, 33321
      • Site 120
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Site 124
  • Illinois
    • Chicago, Illinois, United States, 60616
      • Site 116
    • Wilmette, Illinois, United States, 60091
      • Site 106
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Site 135
    • Munster, Indiana, United States, 46321
      • Site 131
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Site 137
  • Maine
    • Bangor, Maine, United States, 04401
      • Site 138
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Site 123
  • Missouri
    • Washington, Missouri, United States, 63090
      • Site 114
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Site 132
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Site 139
  • New York
    • Buffalo, New York, United States, 14209
      • Site 127
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27517
      • Site 117
    • Raleigh, North Carolina, United States, 27603
      • Site 121
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Site 105
  • Oregon
    • Medford, Oregon, United States, 97504
      • Site 111
    • Tigard, Oregon, United States, 97223
      • Site 147
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004-1108
      • Sie 136
    • Cranberry Township, Pennsylvania, United States, 16066
      • Site 128
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Site 108
  • Texas
    • Lakeway, Texas, United States, 78734
      • Site 126
    • San Antonio, Texas, United States, 78215
      • Site 142
    • San Antonio, Texas, United States, 78240
      • Site 101
    • The Woodlands, Texas, United States, 77380
      • Site 115
  • Utah
    • Ogden, Utah, United States, 84403
      • Site 149
    • Ogden, Utah, United States, 84405
      • Site 140
  • Virginia
    • Virginia Beach, Virginia, United States, 23452
      • Site 113

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 10 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: SYD-101 0.01%; Sterile topical ophthalmic solution; Other Names: atropine sulfate
Experimental: 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	Drug: SYD-101 0.03%; Sterile topical ophthalmic solution; Other Names: atropine sulfate
Placebo Comparator: 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%	Drug: Vehicle; Sterile topical ophthalmic solution without active ingredient; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean annual myopic progression	Mean annual progression rate of myopia measured in diopters: Spherical Equivalent (SE) as measured by cycloplegic autorefraction.	Month 36
Time to progression of myopia >0.75 D (diopters)	Progression of myopia measured as Spherical Equivalent (SE) via cycloplegic autorefraction.	Up to 36 months (from date of randomization until date myopia progresses >0.75 D)
Proportion of participants with annual myopia progression rate <=0.50 D/year	Mean annual progression rate of myopia	Through Month 36
Proportion of participants with annual myopia progression rate <=0.25 D/year	Mean annual progression rate of myopia	Through Month 36
Proportion of participants with annual myopia progression rate > 0.50 D/year	Mean annual progression rate of myopia	Month 36
Mean change from baseline in axial length (subset only)	Measured by cycloplegic biometry	Baseline to Month 36

Collaborators and Investigators

• Sponsor: Sydnexis, Inc.

Publications and helpful links

General Publications

• 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

Helpful Links

• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2019
• Primary Completion (Actual): May 2, 2024
• Study Completion (Actual): May 1, 2025

Study Registration Dates

• First Submitted: April 12, 2019
• First Submitted That Met QC Criteria: April 16, 2019
• First Posted (Actual): April 18, 2019

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Children; Myopia
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Organic Chemicals; Heterocyclic Compounds; Alkaloids; Aza Compounds; Heterocyclic Compounds, Bridged-Ring; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Atropine
• Other Study ID Numbers: SYD-101-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No