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

February 13, 2024 updated by: Sydnexis, Inc.

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

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This will be a 5-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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1140
        • Site 205
    • Oberosterreich
      • Linz, Oberosterreich, Austria, 4021
        • Site 203
    • Styria
      • Graz, Styria, Austria, 8036
        • Site 204
  • 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, 06708
        • Site 150
      • Danbury, Connecticut, United States, 06810
        • Site 102
    • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 12 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1: SYD-101 Dose 1; Part 2: SYD-101 Dose 1
1 drop in each eye at bedtime.
Drug: SYD-101 Dose 1
Sterile topical ophthalmic solution
Other Names:
  • atropine sulfate
Experimental: Part 1: SYD-101 Dose 1; Part 2: Vehicle
1 drop in each eye at bedtime.
Drug: SYD-101 Dose 1
Sterile topical ophthalmic solution
Other Names:
  • atropine sulfate
Drug: Vehicle
Sterile topical ophthalmic solution without active ingredient
Other Names:
  • Placebo
  • Control
Experimental: Part 1: SYD-101 Dose 2; Part 2: SYD-101 Dose 2
1 drop in each eye at bedtime.
Drug: SYD-101 Dose 2
Sterile topical ophthalmic solution
Other Names:
  • atropine sulfate
Experimental: Part 1: SYD-101 Dose 2; Part 2: Vehicle
1 drop in each eye at bedtime.
Drug: Vehicle
Sterile topical ophthalmic solution without active ingredient
Other Names:
  • Placebo
  • Control
Drug: SYD-101 Dose 2
Sterile topical ophthalmic solution
Other Names:
  • atropine sulfate
Placebo Comparator: Part 1: Vehicle; Part 2: SYD-101 Dose 2
1 drop in each eye at bedtime.
Drug: Vehicle
Sterile topical ophthalmic solution without active ingredient
Other Names:
  • Placebo
  • Control
Drug: SYD-101 Dose 2
Sterile topical ophthalmic solution
Other Names:
  • atropine sulfate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myopic progression >0.75 D (diopters)
Time Frame: Month 36
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
Time Frame: Month 36
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)
Time Frame: Up to 36 months (from date of randomization until date myopia progresses >0.75 D)
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
Time Frame: Through Month 36
Mean annual progression rate of myopia
Through Month 36
Proportion of participants with annual myopia progression rate <=0.25 D/year
Time Frame: Through Month 36
Mean annual progression rate of myopia
Through Month 36
Proportion of participants with annual myopia progression rate > 0.50 D/year
Time Frame: Month 36
Mean annual progression rate of myopia
Month 36
Mean change from baseline in axial length
Time Frame: Baseline to Month 36
Measured by cycloplegic biometry
Baseline to Month 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sydnexis, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2019

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 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)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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