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

Myopia Clinical Trial

— EUCALYPTUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

• Verified date: September 2023
• Source: SightGlass Vision, Inc.
• Contact: Jennifer S Hill, BS
• Phone: 678-361-4877
• Email: jhill[@]sightglassvision.com
• Is FDA regulated: No
• 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.

Related Conditions & MeSH terms

• Juvenile Myopia
• Myopia
• Myopia Progression

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	Bellaire Family Eye Care	Bellaire	Texas
United States	Procare Vision Centers, Inc.	Granville	Ohio
United States	Advanced Eyecare PC	Raytown	Missouri

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