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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06034327
Other study ID # CPRO-2304-001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 18, 2023
Est. completion date June 30, 2025

Study information

Verified date May 2024
Source SightGlass Vision, Inc.
Contact Jennifer S Hill, BS
Phone 678-361-4877
Email jhill@sightglassvision.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date June 30, 2025
Est. primary completion date April 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 8 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Single vision, impact-resistant spectacle lenses; Test Arm
Use of single vision, impact-resistant spectacle lenses may reduce the rate of progression of juvenile myopia
Single vision, impact-resistant spectacle lenses; Control Arm
Single vision, impact-resistant spectacle lenses

Locations

Country Name City State
United States Athens Eye Care Athens Ohio
United States Texas State Optical - Dowlen Beaumont Texas
United States Bellaire Family Eye Care Bellaire Texas
United States New England College of Optometry Boston Massachusetts
United States Ilinois College of Optometry Chicago Illinois
United States Procare Vision Centers, Inc. Granville Ohio
United States Omega Vision Center Longwood Florida
United States Marietta Eye Clinic Marietta Georgia
United States Elsa Pao, OD Oakland California
United States Kannarr Eye Care Pittsburg Kansas
United States Advanced Eyecare PC Raytown Missouri
United States Scripps Poway Eyecare San Diego California
United States Pacific Rims Optometry San Francisco California
United States Paje Optometric Santa Ana California

Sponsors (1)

Lead Sponsor Collaborator
SightGlass Vision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Spherical equivalent refraction Change in spherical equivalent refraction from baseline 12 months
Secondary Axial length Change in axial length from baseline 12 months
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