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Trial record 1 of 1 for:    SYD-101 | Myopia
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The Safety and Efficacy of SYD-101 in Children With Myopia (STAAR)

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ClinicalTrials.gov Identifier: NCT03918915
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : December 4, 2019
Sponsor:
Information provided by (Responsible Party):
Sydnexis, Inc.

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
Nearsightedness Near Sightedness Near-sightedness Drug: SYD-101 Dose 1 Drug: SYD-101 Dose 2 Drug: Vehicle 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 840 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 : April 24, 2019
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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 Name: 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 Name: atropine sulfate

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Mean change in axial length [ Time Frame: Baseline to Month 36 ]
    Measured by cycloplegic biometry



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03918915


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information please email: SYDNEXISSYD101001ClinicalTrial.sm@ppdi.com

  Show 40 Study Locations
Sponsors and Collaborators
Sydnexis, Inc.

Additional Information:
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Responsible Party: Sydnexis, Inc.
ClinicalTrials.gov Identifier: NCT03918915     History of Changes
Other Study ID Numbers: SYD-101-001
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Myopia
Refractive Errors
Eye Diseases
Atropine
Ophthalmic Solutions
Pharmaceutical Solutions
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action