Efficacy in Controlling Myopia in Young Children Using a Novel Spectacle Lens
This is a conventional efficacy trial to validate the results from previous clinical trials for younger children; the 12-month efficacy results will be used to predict the 3-year treatment efficacy. This is a randomized, controlled (1:1), multisite, subject- and observer-masked, 2-arm parallel group study.
Conditions:
🦠 Myopia 🦠 Juvenile Myopia 🦠 Myopia Progression
🗓️ Study Start (Actual) 18 September 2023
🗓️ Primary Completion (Estimated) 30 April 2025
✅ Study Completion (Estimated) 30 June 2025
👥 Enrollment (Estimated) 150
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Oakland, California, United States
📍 San Diego, California, United States
📍 San Francisco, California, United States
📍 Santa Ana, California, United States
📍 Longwood, Florida, United States
📍 Marietta, Georgia, United States
📍 Chicago, Illinois, United States
📍 Pittsburg, Kansas, United States
📍 Boston, Massachusetts, United States
📍 Raytown, Missouri, United States
📍 Athens, Ohio, United States
📍 Granville, Ohio, United States
📍 Beaumont, Texas, United States
📍 Bellaire, Texas, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Children 6 - 8 years of age (inclusive) at time of informed consent/assent;
    • 2. Spherical equivalent refractive error between -0.75 and -4.50 D inclusive (by manifest refraction) in each eye;
    • 3. Astigmatism if present, less than or equal to -1.25 DC (by manifest refraction) in each eye;
    • 4. Best corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye;
    • 5. The difference in spherical equivalent power between the two eyes (anisometropia based on manifest refraction) must be less than or equal to 1.50 D;
    • 6. Agree to wear the assigned spectacles constantly except for sleeping, swimming, or other activities in which spectacle wear would be dangerous or otherwise not possible (minimum of 10 hours per day);
    • 7. Ability to comply with study procedures, including high and low contrast visual acuity, axial length, and cycloplegic autorefraction measurements taken for both eyes at the baseline visit;
    • 8. Willingness to participate in the trial for 24 months without contact lens wear;
    • 9. The subject's parent(s) or legal guardian(s) must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form.

    Exclusion Criteria:

    • 1. Subject has previously or currently wears contact lenses (greater than 1-month usage);
    • 2. Current or prior use of bifocals, progressive addition spectacle lenses
    • 3. Current or prior use of any myopia control treatment (e.g., atropine, multifocal contact lenses, orthokeratology);
    • 4. Amblyopia in either eye;
    • 5. Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction;
    • 6. Any ocular or systemic conditions that could influence refractive development or status \[e.g., keratoconus, congenital glaucoma, ocular trauma, diabetes, Marfan syndrome or other connective tissue disorder, Down's syndrome, family history of poor night vision (to prevent against enrolling subjects with congenital stationary night blindness)\];
    • 7. Known allergy to proparacaine, tetracaine, or tropicamide;
    • 8. Participation in any investigational clinical study within 30 days of the Baseline visit;
    • 9. Subject's sibling or other household member is already enrolled in this trial.
Ages Eligible for Study: 6 Years to 8 Years (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ 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 Registration Dates

  • First Submitted 5 September 2023
  • First Submitted that Met QC Criteria 5 September 2023
  • First Posted 13 September 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 24 May 2024
  • Last Update Posted 28 May 2024
  • Last Verified May 2024