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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-04

Study Completion Date

2019-06-06

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

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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

Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

paired-eye design

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ticon Aspherical Daily Disposable Soft Contact Lens

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.

Group Type EXPERIMENTAL

soft contact lens

Intervention Type DEVICE

Ticon Daily Soft Contact Lens

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.

Group Type PLACEBO_COMPARATOR

soft contact lens

Intervention Type DEVICE

Interventions

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soft contact lens

Intervention Type DEVICE

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

Minimum Eligible Age

9 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No