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

Study Overview
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Brief Summary
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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.

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

Conditions
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Myopia, Juvenile Myopia, Myopia Progression

Intervention / Treatment
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* Device: Single vision, impact-resistant spectacle lenses; Test Arm
* Device: Single vision, impact-resistant spectacle lenses; Control Arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Arm 1<br>Single vision, impact-resistant spectacle lenses | Device: Single vision, impact-resistant spectacle lenses; Test Arm<br>* Use of single vision, impact-resistant spectacle lenses may reduce the rate of progression of juvenile myopia<br>|
| Other: Test Arm 2<br>Single vision, impact-resistant spectacle lenses | Device: Single vision, impact-resistant spectacle lenses; Control Arm<br>* Single vision, impact-resistant spectacle lenses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spherical equivalent refraction | Change in spherical equivalent refraction from baseline | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axial length | Change in axial length from baseline | 12 months |