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

• Sponsor: SightGlass Vision, Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06034327
• Collaborator: (none)
• Enrollment: 150
• Locations: 4
• Arms: 2
• Anticipated Duration (Months): 21
• Patients Per Site: 37.5
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia; Juvenile Myopia; Myopia Progression	Device: Single vision, impact-resistant spectacle lenses; Test Arm; Device: Single vision, impact-resistant spectacle lenses; Control Arm	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Participants and parents of participants will be masked. Investigational site staff tasked with measuring key primary variables will be masked.
• Primary Purpose: Treatment
• Official Title: Efficacy in Controlling Myopia in Young Children Using a Novel Spectacle Lens
• Anticipated Study Start Date: Sep 30, 2023
• Anticipated Primary Completion Date: Apr 30, 2025
• Anticipated Study Completion Date: Jun 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test Arm 1 Single vision, impact-resistant spectacle lenses	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
Other: Test Arm 2 Single vision, impact-resistant spectacle lenses	Device: Single vision, impact-resistant spectacle lenses; Control Arm; Single vision, impact-resistant spectacle lenses

Outcome Measures

Primary Outcome Measures

1. Spherical equivalent refraction [12 months]

   Change in spherical equivalent refraction from baseline

Secondary Outcome Measures

1. Axial length [12 months]

   Change in axial length from baseline

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 8 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Advanced Eyecare PC	Raytown	Missouri	United States	64133
2	Athens Eye Care	Athens	Ohio	United States	45701
3	Procare Vision Centers, Inc.	Granville	Ohio	United States	43023
4	Bellaire Family Eye Care	Bellaire	Texas	United States	77401

Sponsors and Collaborators

• SightGlass Vision, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: SightGlass Vision, Inc.
• ClinicalTrials.gov Identifier: NCT06034327
• Other Study ID Numbers: CPRO-2304-001
• First Posted: Sep 13, 2023
• Last Update Posted: Sep 13, 2023
• Last Verified: Sep 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Myopia

Study Results

No Results Posted as of Sep 13, 2023