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NearsightednessPhase 3STARNCT03918915

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

A Phase 3 study testing SYD-101 0.01% and SYD-101 0.03% in people with Nearsightedness and Near Sightedness, run by Sydnexis, Inc. at 47 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 3 to 14 years
What is being tested?
SYD-101 0.01% and SYD-101 0.03%
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
852 participants
Where
47 sitesin 3 countries
Study dates
24 Apr 2019to 1 May 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

47 sites in 3 countries.

47 sites in 3 countries

United States41 sites

  • Site 139

    Albuquerque, New Mexico, 87109

  • Sie 136

    Bala-Cynwyd, Pennsylvania, 19004-1108

  • Site 138

    Bangor, Maine, 04401

  • Site 123

    Boston, Massachusetts, 02111

  • Site 127

    Buffalo, New York, 14209

  • Site 117

    Chapel Hill, North Carolina, 27517

  • Site 108

    Charleston, South Carolina, 29425

  • Site 116

    Chicago, Illinois, 60616

  • Site 130

    Colorado Springs, Colorado, 80920

  • Site 128

    Cranberry Township, Pennsylvania, 16066

  • Site 102

    Danbury, Connecticut, 06810

  • Site 105

    Fargo, North Dakota, 58103

  • Site 100

    Fort Collins, Colorado, 80528

  • Site 122

    Fort Lauderdale, Florida, 33309

  • Site 132

    Henderson, Nevada, 89052

  • Site 135

    Indianapolis, Indiana, 46202

  • Site 143

    Irwindale, California, 91706

  • Site 109

    Jupiter, Florida, 33477

  • Site 126

    Lakeway, Texas, 78734

  • Site 124

    Marietta, Georgia, 30060

  • Site 111

    Medford, Oregon, 97504

  • Site 131

    Munster, Indiana, 46321

  • Site 149

    Ogden, Utah, 84403

  • Site 140

    Ogden, Utah, 84405

  • Site 144

    Pasadena, California, 91105

  • Site 137

    Pittsburg, Kansas, 66762

  • Site 121

    Raleigh, North Carolina, 27603

  • Site 142

    San Antonio, Texas, 78215

  • Site 101

    San Antonio, Texas, 78240

  • Site 148

    San Diego, California, 92127

  • Site 104

    San Diego, California, 92131

  • Site 110

    Santa Barbara, California, 93110

  • Site 133

    Sunnyvale, California, 94087

  • Site 119

    Sweetwater, Florida, 33182

  • Site 120

    Tamarac, Florida, 33321

  • Site 115

    The Woodlands, Texas, 77380

  • Site 147

    Tigard, Oregon, 97223

  • Site 113

    Virginia Beach, Virginia, 23452

  • Site 114

    Washington, Missouri, 63090

  • Site 150

    Waterbury, Connecticut, 06708

  • Site 106

    Wilmette, Illinois, 60091

Other trials in United States

Austria3 sites

  • Site 204

    Graz, Styria, 8036

  • Site 203

    Linz, Upper Austria, 4021

  • Site 205

    Vienna, 1140

Other trials in Austria

Slovakia3 sites

  • Site 202

    Bratislava, 833 40

  • Site 201

    Trebišov, 075 01

  • Site 200

    Trenčín, 91108

Other trials in Slovakia

About this study

Official title: 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.

Read the 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.

Being tested
SYD-101 0.01%, SYD-101 0.03%, Vehicle
Keywords
Children, Myopia
Medical subject headings
Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SYD-101 0.01%Drug

    Also called atropine sulfate

    Sterile topical ophthalmic solution

  • SYD-101 0.03%Drug

    Also called atropine sulfate

    Sterile topical ophthalmic solution

  • VehicleDrug

    Also called Placebo

    Sterile topical ophthalmic solution without active ingredient

Study groups in NCT03918915
Study groupRoleWhat they receive
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
Receives: Drug: SYD-101 0.01%
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
Receives: Drug: SYD-101 0.03%
VehiclePlacebo 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%
Receives: Drug: Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Month 36

Secondary outcomes (6)

  1. Mean Annual Myopic Progression

    Mean annual progression rate of myopia measured in diopters: Spherical Equivalent (SE) as measured by cycloplegic autorefraction.

    Measured: Month 36

  2. Proportion of Participants With Annual Myopia Progression Rate >=-0.50 D/Year

    Proportion of participants with annual progression rate of myopia no worse than -0.50 D/year

    Measured: Through Month 36

  3. Proportion of Participants With Annual Myopia Progression Rate >=-0.25 D/Year

    Proportion of participants with annual progression rate of myopia no worse than -0.25D/year

    Measured: Through Month 36

  4. Proportion of Participants With Increase of Myopia More Than -0.50 D

    Proportion of participants with increase of myopia more than -0.50D

    Measured: Month 36

  5. Time to Progression of Myopia <-0.75 D (Diopters)

    Time (days) to confirmed myopic progression of worse than -0.75D. Time to Progression (days) 95% CI is calculated for the median.

    Measured: Up to 36 months (from date of randomization until date myopia progresses < -0.75 D)

  6. Mean Change From Baseline in Axial Length (Subset Only)

    Mean change from baseline in axial length at sites with requisite equipment

    Measured: Baseline to Month 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2019
  2. Study start24 Apr 2019
  3. Primary completion2 May 2024
  4. Study completion1 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
852 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03918915
Sponsor's protocol ID
SYD-101-001
Acronym
STAR
Status last verified
Apr 2026
First submitted
12 Apr 2019
Last updated
30 Jul 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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

  • Korenfeld 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 May;15(5):1685-1703. doi: 10.1007/s40123-026-01341-0. Epub 2026 Mar 23.

    PubMed 41870844

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SYD-101 0.01% and SYD-101 0.03% in people with Nearsightedness and Near Sightedness, run by Sydnexis, Inc. at 47 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in United States, Austria, Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Myopic Progression <-0.75 D (Diopters) (time frame: Month 36). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03918915, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.

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