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

Not Applicable

Recruiting

• Conditions: Myopia Progression; Juvenile Myopia; Myopia
• Interventions: Device: Single vision, impact-resistant spectacle lenses; Control Arm; Device: Single vision, impact-resistant spectacle lenses; Test Arm

• Registration Number: NCT06034327
• Lead Sponsor: SightGlass Vision, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-05
• Study First Submitted QC: 2023-09-05
• Study First Posted: 2023-09-13
• Study Start: 2023-09-18
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20
• Primary Completion: 2026-01-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test Arm 2	Single vision, impact-resistant spectacle lenses; Control Arm	Single vision, impact-resistant spectacle lenses
Test Arm 1	Single vision, impact-resistant spectacle lenses; Test Arm	Single vision, impact-resistant spectacle lenses

Primary Outcome Measures

Name	Time	Method
Spherical equivalent refraction	12 months	Change in spherical equivalent refraction from baseline

Secondary Outcome Measures

Name	Time	Method
Axial length	12 months	Change in axial length from baseline

Trial Locations

Locations (14)

Elsa Pao, OD; 🇺🇸 Oakland, California, United States

Omega Vision Center; 🇺🇸 Longwood, Florida, United States

Advanced Eyecare PC; 🇺🇸 Raytown, Missouri, 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

Scripps Poway Eyecare; 🇺🇸 San Diego, California, United States

Pacific Rims Optometry; 🇺🇸 San Francisco, California, United States

Paje Optometric; 🇺🇸 Santa Ana, California, United States

Marietta Eye Clinic; 🇺🇸 Marietta, Georgia, United States

Ilinois College of Optometry; 🇺🇸 Chicago, Illinois, United States

New England College of Optometry; 🇺🇸 Boston, Massachusetts, United States

Procare Vision Centers, Inc.; 🇺🇸 Granville, Ohio, United States

Kannarr Eye Care; 🇺🇸 Pittsburg, Kansas, United States