An Evaluation of the Effectiveness of Dual Focus Soft Contact Lenses in Slowing Mypoia Progression

Study Overview
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Brief Summary
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The purpose of this study is to determine whether a new type of soft contact lens with a unique optical design (dual focus) is effective at slowing the progression of myopia (near-sightedness) in children.

Detailed Description
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Subjects were randomized to wear test or control soft contact lens to determine whether a new type of soft contact lens with a unique optical design (dual focus) is effective at slowing the progression of myopia (near-sightedness) in children.

Official Title
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A Multicentre Dispensing Clinical Evaluation of MiSight® Lenses

Conditions
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Myopia

Intervention / Treatment
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* Device: Dual Focus Soft Contact Lens
* Device: Single Vision Soft Contact Lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be between 8 and 12 years of age inclusive. Best-corrected visual acuity by manifest refraction of +0.10 logMAR. Spherical Equivalent Refractive Error between -0.75 and -4.00 D inclusive astigmatism: < -0.75 D and anisometropia: < 1.00 D Possess wearable and visually functional eyeglasses. Agree to wear the assigned contact lenses for a minimum of 10 hours per day, - at least 6 days per week, for the duration of the 3 year study. Exclusion Criteria: Subject has previously or currently wears contact lenses or rigid gas permeable contact lenses, including orthokeratology lenses. Subject is currently or within 30 days prior to this study has been an active participant in another clinical study. Current or prior use of bifocals, progressive addition lenses, atropine, pirenzepine or ANY other myopia control treatment. Regular use of ocular medications (prescription or over-the-counter), artificial tears, or wetting agents. Current use of systemic medications which may significantly affect contact lens wear, tear film production, pupil size, accommodation or refractive state. A known allergy to fluorescein, benoxinate, proparacaine or tropicamide. Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction. Any ocular, systemic or neuro-developmental conditions that could influence refractive development.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dual Focus Soft Contact Lens<br>Dual Focus Soft Contact Lens | Device: Dual Focus Soft Contact Lens<br> <br> |
| Placebo Comparator: Single Vision Soft Contact Lens<br>Single Vision Soft Contact Lens | Device: Single Vision Soft Contact Lens<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Refractive Error Relative to Baseline | Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 12 months, relative to baseline. | 12 months | 
| Change in Refractive Error Relative to Baseline | Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 24 months, relative to baseline. | 24 months | 
| Change in Refractive Error Relative to Baseline | Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 36 months, relative to baseline. | 36 months | 
| Change in Axial Length Relative to Baseline | Mean change in axial length measurement, in millimeters at 12 months, relative to baseline. | 12 months | 
| Change in Axial Length Relative to Baseline | Mean change in axial length measurement, in millimeters at 24 months, relative to baseline. | 24 months | 
| Change in Axial Length Relative to Baseline | Mean change in axial length measurement, in millimeters at 36 months, relative to baseline. | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Biomicroscopic Findings Greater Than Grade 2 | Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe). | Baseline | 
| Number of Participants With Biomicroscopic Findings Greater Than Grade 2 | Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe). | 12 months | 
| Number of Participants With Biomicroscopic Findings | Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe). | 24 months | 
| Number of Participants With Biomicroscopic Findings Greater Than Grade 2. | Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe). | 36 months | 
| Incidence of Adverse Events | Cumulative incidence of adverse events. | 12 months | 
| Incidence of Adverse Events | Cumulative incidence of adverse events. | 24 months | 
| Incidence of Adverse Events | Cumulative incidence of adverse events. | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myopia progression, myopia control