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

Recruiting now · Not applicable

Conditions studied: Myopia, Juvenile Myopia, Myopia Progression

In brief

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.

Key facts

Study ID

NCT06034327

Run by

SightGlass Vision, Inc.

People needed

150

Starts

2023-09-18

Expected to finish

2027-03-31

Last updated by the study team

2025-12-29

Who can join

Age: 6 and older, up to 8. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Children 6 - 8 years of age (inclusive) at time of informed consent/assent;
• Spherical equivalent refractive error between -0.75 and -4.50 D inclusive (by manifest refraction) in each eye;
• Astigmatism if present, less than or equal to -1.25 DC (by manifest refraction) in each eye;
• Best corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye;
• 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;
• 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);
• 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;
• Willingness to participate in the trial for 24 months without contact lens wear;
• 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.

You may not qualify if…

• Subject has previously or currently wears contact lenses (greater than 1-month usage);
• Current or prior use of bifocals, progressive addition spectacle lenses
• Current or prior use of any myopia control treatment (e.g., atropine, multifocal contact lenses, orthokeratology);
• Amblyopia in either eye;
• Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction;
• 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)];
• Known allergy to proparacaine, tetracaine, or tropicamide;
• Participation in any investigational clinical study within 30 days of the Baseline visit;
• Subject's sibling or other household member is already enrolled in this trial.

Where it is running

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

Full record on ClinicalTrials.gov

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