Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    sydnexis
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03918915
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Sydnexis, Inc.

Tracking Information
First Submitted Date  ICMJE April 12, 2019
First Posted Date  ICMJE April 18, 2019
Last Update Posted Date September 2, 2020
Actual Study Start Date  ICMJE April 24, 2019
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2019)
  • 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.
  • 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.
  • Mean change in axial length [ Time Frame: Baseline to Month 36 ]
    Measured by cycloplegic biometry
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Safety and Efficacy of SYD-101 in Children With Myopia
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Nearsightedness
  • Near Sightedness
  • Near-sightedness
Intervention  ICMJE
  • Drug: SYD-101 Dose 1
    Sterile topical ophthalmic solution
    Other Name: atropine sulfate
  • 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
Study Arms  ICMJE
  • Experimental: Part 1: SYD-101 Dose 1; Part 2: SYD-101 Dose 1
    1 drop in each eye at bedtime.
    Intervention: Drug: SYD-101 Dose 1
  • Experimental: Part 1: SYD-101 Dose 1; Part 2: Vehicle
    1 drop in each eye at bedtime.
    Interventions:
    • Drug: SYD-101 Dose 1
    • Drug: Vehicle
  • Experimental: Part 1: SYD-101 Dose 2; Part 2: SYD-101 Dose 2
    1 drop in each eye at bedtime.
    Intervention: Drug: SYD-101 Dose 2
  • Experimental: Part 1: SYD-101 Dose 2; Part 2: Vehicle
    1 drop in each eye at bedtime.
    Interventions:
    • Drug: SYD-101 Dose 2
    • Drug: Vehicle
  • Placebo Comparator: Part 1: Vehicle; Part 2: SYD-101 Dose 2
    1 drop in each eye at bedtime.
    Interventions:
    • Drug: SYD-101 Dose 2
    • Drug: Vehicle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 16, 2019)
840
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2024
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information please email: SYDNEXISSYD101001ClinicalTrial.sm@ppdi.com
Listed Location Countries  ICMJE Austria,   Slovakia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03918915
Other Study ID Numbers  ICMJE SYD-101-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sydnexis, Inc.
Study Sponsor  ICMJE Sydnexis, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sydnexis, Inc.
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP