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

NCT06034327 | Recruiting FDA Device

• 1 other identifier: CPRO-2304-001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 14

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.

Conditions

Juvenile Myopia; Myopia Progression; Myopia

Outcome Measures

Primary Outcomes (1)

• Spherical equivalent refraction

  Change in spherical equivalent refraction from baseline

  12 months

Secondary Outcomes (1)

• Axial length

  12 months

Study Arms (2)

Test Arm 1

EXPERIMENTAL

Single vision, impact-resistant spectacle lenses

Device: Single vision, impact-resistant spectacle lenses; Test Arm

Test Arm 2

OTHER

Single vision, impact-resistant spectacle lenses

Device: Single vision, impact-resistant spectacle lenses; Control Arm

Interventions

Single vision, impact-resistant spectacle lenses; Test Arm DEVICE

Use of single vision, impact-resistant spectacle lenses may reduce the rate of progression of juvenile myopia

Test Arm 1

Single vision, impact-resistant spectacle lenses; Control Arm DEVICE

Single vision, impact-resistant spectacle lenses

Test Arm 2

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• SightGlass Vision, Inc.: lead

Study Sites (14)

Elsa Pao, OD

Oakland, California, 94607, United States

RECRUITING

Scripps Poway Eyecare

San Diego, California, 92131, United States

RECRUITING

Pacific Rims Optometry

San Francisco, California, 94127, United States

RECRUITING

Paje Optometric

Santa Ana, California, 92704, United States

RECRUITING

Omega Vision Center

Longwood, Florida, 32779, United States

RECRUITING

Marietta Eye Clinic

Marietta, Georgia, 30060, United States

RECRUITING

Ilinois College of Optometry

Chicago, Illinois, 60616, United States

RECRUITING

Kannarr Eye Care

Pittsburg, Kansas, 66762, United States

RECRUITING

New England College of Optometry

Boston, Massachusetts, 02115, United States

RECRUITING

Advanced Eyecare PC

Raytown, Missouri, 64133, United States

RECRUITING

Athens Eye Care

Athens, Ohio, 45701, United States

RECRUITING

Procare Vision Centers, Inc.

Granville, Ohio, 43023, United States

RECRUITING

Texas State Optical - Dowlen

Beaumont, Texas, 77706, United States

RECRUITING

Bellaire Family Eye Care

Bellaire, Texas, 77401, United States

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Jennifer S Hill, BS

CONTACT

678-361-4877; jhill@sightglassvision.com

Vanessa Tasso, MA, MBA

CONTACT

949-751-7039; vtasso@sightglassvision.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and parents of participants will be masked. Investigational site staff tasked with measuring key primary variables will be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 13, 2023
• Study Start: September 18, 2023
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

US (14)