To Evaluate the Efficacy and Safety of Aspherical Soft Contact Lens in Myopia Control

Study Overview
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Brief Summary
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The objective of this study is to demonstrate that the Ticon Aspherical Daily Disposable Soft Contact Lens could retard myopia progress in youth

Detailed Description
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This study is designed as a prospective, multicenter, randomized, double blinded, controlled, paired-eye comparison study. At least 60 evaluable subjects with myopia progression ≧ 0.75 D in the past 12 months will be recruited from 2 study sites. The experimental soft contact lens with aspherical design (Ticon Aspherical) will be randomly assigned to either the right eye or the left eye of the subject , then the fellow eye will be assigned a control lens with a single vision distance (SVD) soft contact lens (Ticon). Both lenses will be worn at least 8 hours a day, 5 days a week for 1 year. All lenses will be replaced every day. Brief assessment of the clinical findings will be followed up for one year at 1 day, 1 week, 1, 3, 6, 9, 12 months upon allocation. The primary efficacy outcome is change in spherical equivalent refraction (SER) measured by cycloplegic autorefraction over 12 months. The secondary outcome is change in axial eye length (AXL) measured over 12 months. The secondary outcome measure is used to corroborate any changes in SER

Official Title
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A Prospective Randomized Control Study to Evaluate the Effect of Ticon Aspherical Daily Disposable Soft Contact Lens on Myopia Control

Conditions
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Myopia

Intervention / Treatment
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* Device: soft contact lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Myopia (SE) between -1.00D to -8.00D Astigmatism less than or equal to 1.75D Myopia progression ≧0.75 D in the past 12 months Best Corrected Visual Acuity (BCVA): 0.9 Snellen or better Willingness to wear contact lens constantly Availability for follow-up for at least 1 year Parent's understanding and acceptance have an acceptable surrogate capable of giving legally authorized consent on behalf of the subject Exclusion Criteria: Anisometropia greater than 2.00D Presence of ocular disease preventing wear of contact lens Severe ocular or systemic allergies Taking any medication that might have an impact on contact lens wear or that might influence the outcome of the clinical trial Ocular or systemic condition that might affect refractive development Atropine/Pirenzepine treatment for myopia control in the past 1 month Prior use of Ortho-K lenses Dry eye with Schimer Test (basal secretion test) < 5mm/5min or other physical condition that would contraindicate contact lens wear

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Interventional Model Description: paired-eye design
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ticon Aspherical Daily Disposable Soft Contact Lens<br>The subject will be requested to wear lens 8 hours a day, 5 days a week at least. The contact lens will be worn and replaced every day. All subjects will be followed for 1 year post device allocation with a brief clinical assessment at 1 day, 1 week, 1, 3, 6, 9, 12 months. | Device: soft contact lens<br> <br> |
| Placebo Comparator: Ticon Daily Soft Contact Lens<br>The subject will be requested to wear lens 8 hours a day, 5 days a week at least. The contact lens will be worn and replaced every day. All subjects will be followed for 1 year post device allocation with a brief clinical assessment at 1 day, 1 week, 1, 3, 6, 9, 12 months. | Device: soft contact lens<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spherical Equivalent Refraction (SER) | The change in spherical equivalent refraction (SER) measured by cycloplegic autorefraction over 12 months. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axial Eye Length (AXL) | The change in axial eye length (AXL) measured over 12 months. Axial length is measured after cycloplegia using optical biometry. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myopia control, soft contact lens, eye diseases