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

Sponsor
Sydnexis, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03918915
Collaborator
(none)
852
Enrollment
47
Locations
5
Arms
73.3
Anticipated Duration (Months)
18.1
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
852 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 24, 2019
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

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:
  • Control
  • Placebo

    		•
    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: SYD-101 Dose 2
    Sterile topical ophthalmic solution
    Other Names:
  • atropine sulfate

    • Drug: Vehicle
    Sterile topical ophthalmic solution without active ingredient
    Other Names:
  • Control
  • Placebo

    		•
    Placebo Comparator: Part 1: Vehicle; 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

    • Drug: Vehicle
    Sterile topical ophthalmic solution without active ingredient
    Other Names:
  • Control
  • Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Myopic progression >0.75 D (diopters) [Month 36]

      Proportion of participants with confirmed myopic progression >0.75 D (diopters), based on SE (spherical equivalent) as measured by cycloplegic autorefraction

    Secondary Outcome Measures

    1. Mean annual myopic progression [Month 36]

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

    2. Time to progression of myopia >0.75 D (diopters) [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.

    3. Mean change in axial length [Baseline to Month 36]

      Measured by cycloplegic biometry

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 14 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site 143 Irwindale California United States 91706
    2 Site 144 Pasadena California United States 91105
    3 Site 148 San Diego California United States 92127
    4 Site 104 San Diego California United States 92131
    5 Site 110 Santa Barbara California United States 93110
    6 Site 133 Sunnyvale California United States 94087
    7 Site 130 Colorado Springs Colorado United States 80920
    8 Site 100 Fort Collins Colorado United States 80528
    9 Site 150 Danbury Connecticut United States 06708
    10 Site 102 Danbury Connecticut United States 06810
    11 Site 119 Doral Florida United States 33172
    12 Site 122 Fort Lauderdale Florida United States 33309
    13 Site 109 Jupiter Florida United States 33477
    14 Site 120 Tamarac Florida United States 33321
    15 Site 124 Marietta Georgia United States 30060
    16 Site 116 Chicago Illinois United States 60616
    17 Site 106 Wilmette Illinois United States 60091
    18 Site 135 Indianapolis Indiana United States 46202
    19 Site 131 Munster Indiana United States 46321
    20 Site 137 Pittsburg Kansas United States 66762
    21 Site 138 Bangor Maine United States 04401
    22 Site 123 Boston Massachusetts United States 02111
    23 Site 114 Washington Missouri United States 63090
    24 Site 132 Henderson Nevada United States 89052
    25 Site 139 Albuquerque New Mexico United States 87109
    26 Site 127 Buffalo New York United States 14209
    27 Site 117 Chapel Hill North Carolina United States 27517
    28 Site 121 Raleigh North Carolina United States 27603
    29 Site 105 Fargo North Dakota United States 58103
    30 Site 111 Medford Oregon United States 97504
    31 Site 147 Tigard Oregon United States 97223
    32 Sie 136 Bala-Cynwyd Pennsylvania United States 19004-1108
    33 Site 128 Cranberry Township Pennsylvania United States 16066
    34 Site 108 Charleston South Carolina United States 29425
    35 Site 126 Lakeway Texas United States 78734
    36 Site 142 San Antonio Texas United States 78215
    37 Site 101 San Antonio Texas United States 78240
    38 Site 115 The Woodlands Texas United States 77380
    39 Site 149 Ogden Utah United States 84403
    40 Site 140 Ogden Utah United States 84405
    41 Site 113 Virginia Beach Virginia United States 23452
    42 Site 203 Linz Oberosterreich Austria 4021
    43 Site 204 Graz Styria Austria 8036
    44 Site 205 Vienna Austria 1140
    45 Site 202 Bratislava Slovakia 833 40
    46 Site 201 Trebišov Slovakia 075 01
    47 Site 200 Trenčín Slovakia 91108

    Sponsors and Collaborators

    • Sydnexis, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Sydnexis, Inc.
    ClinicalTrials.gov Identifier:
    NCT03918915
    Other Study ID Numbers:
    • SYD-101-001
    First Posted:
    Apr 18, 2019
    Last Update Posted:
    Feb 4, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sydnexis, Inc.
    Children
    Myopia
    Additional relevant MeSH terms:
    Myopia
    Atropine

    Study Results

    No Results Posted as of Feb 4, 2022