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NCT06034327NARecruitingAccepts Healthy Volunteers

Efficacy in Controlling Myopia in Young Children Using a Novel Spectacle Lens

SightGlass Vision, Inc.

Start Date

9/18/2023

Completion Date

3/31/2027

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.

Eligibility Criteria

Age Range: 6 years to 8 years

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.

Interventions

DEVICE

Single vision, impact-resistant spectacle lenses; Test Arm

DEVICE

Single vision, impact-resistant spectacle lenses; Control Arm

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

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Conditions

MyopiaJuvenile MyopiaMyopia Progression

Locations

Elsa Pao, OD

Oakland, California 94607

United States

Scripps Poway Eyecare

San Diego, California 92131

United States

Pacific Rims Optometry

San Francisco, California 94127

United States

Paje Optometric

Santa Ana, California 92704

United States

Omega Vision Center

Longwood, Florida 32779

United States

Marietta Eye Clinic

Marietta, Georgia 30060

United States

Ilinois College of Optometry

Chicago, Illinois 60616

United States

Kannarr Eye Care

Pittsburg, Kansas 66762

United States

New England College of Optometry

Boston, Massachusetts 02115

United States

Advanced Eyecare PC

Raytown, Missouri 64133

United States

Athens Eye Care

Athens, Ohio 45701

United States

Procare Vision Centers, Inc.

Granville, Ohio 43023

United States

Texas State Optical - Dowlen

Beaumont, Texas 77706

United States

Bellaire Family Eye Care

Bellaire, Texas 77401

United States