To Evaluate the Efficacy and Safety of Multifocal 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 investigate the efficacy and safety of soft lens in myopia control.

Detailed Description
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This is a prospective, randomized, paired eye comparison, double-blind study aims to evaluate the efficacy and safety of Soft Lens in myopia control among schoolchildren. A total of 118 eyes are planned to be enrolled and the expect duration of subject participation will be 48 weeks not including two weeks of screening period. Data such as refractive error, axial length, visual acuity, average wearing hours, self-assessment, adverse events etc. will be collected during the study. A total of 10 visits, i.e. a screening visit, a randomization visit, and 8 treatment visits are planned. Subjects will be encouraged to complete all planned visits.

Official Title
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A Prospective, Randomization, Double-blind Study to Evaluate the Efficacy and Safety of Multifocal Soft Contact Lens in 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: Both genders aged between 6 and 15 years Spherical equivalent refractive error between -1.00D and -10.00D Visual acuity with contact lens of 20/25 or better in each eye Astigmatism less than or equal to 1.50D Anisometropia less than or equal to 1.00D Agree to wear assigned contact lens and able to comply with the study protocol Subjects and/or their legal representatives agree to sign informed consent form Exclusion Criteria: Eye disease or vision problem that may contraindicate/interfere with contact lens wearing, for example: Amblyopia Severe strabismus at investigator's discretion Pathologically dry eye Aphakia Slit lamp findings including but not limited to corneal edema, corneal ulcer, bulbar redness that are more serious than grade 1 Currently ocular infection of any type or inflammation in either eye Oculomotor nerve palsies Pupil or lid abnormality in either eye Severe ocular allergy Anterior segment infection, inflammation or abnormality Corneal vascularization greater than 1 mm of penetration History of herpetic keratitis Use of bifocals, progressive addition lenses, rigid gas permeable contact lenses, orthokeratology lenses, atropine, pirenzepine or any other myopia control treatment within 1 month prior to screening visit Systemic disease that may affect vision or contact lens wearing (e.g. diabetes, Down syndrome), autoimmune disease, infectious disease, or immunosuppressive diseases recorded in medical charts or informed by caregiver Surgically altered eyes (e.g. corneal or refractive surgery, not including stye removal surgery) Receiving any medication for long-term use which may interfere with contact lens wearing, tear film production, pupil size, accommodation or refractive state, such as nasal decongestants (e.g. pseudoephedrine, phenylephrine), antihistamines (e.g. chlorpheniramine, diphenhydramine), Prednisolone or Ritalin (methyphenidate)

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 15 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
Interventional Model Description: Paired-eye comparison
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group A<br>Intervention name: multifocal soft contact lens/single vision soft contact lens Left eye: multifocal soft contact lens Right eye: single vision soft contact lens | Device: soft contact lens<br>* Group A Group B<br>|
| Other: Group B<br>Intervention name: multifocal soft contact lens/single vision soft contact lens Left eye: single vision soft contact lens Right eye: multifocal soft contact lens | Device: soft contact lens<br>* Group A Group B<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective cycloplegic refractive error | Changes in objective cycloplegic refractive error between the two eyes in 48 weeks | 48 weeks | 
| Axial length | Changes in axial length between the two eyes in 48 weeks | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cycloplegic refractive error | Changes in objective cycloplegic refractive error between the two eyes from baseline after treatment | 12, 24, and 36 weeks | 
| Axial length | Changes in axial length between the two eyes from baseline after treatment | 12, 24, and 36 weeks | 
| Myopia progression and axial elongation | Percent reductions of myopia progression and axial elongation | during 48 weeks | 
| Self-assessment by questionnaire 1 | Analysis of subject self-assessment | during 48 weeks | 
| Self-assessment by questionnaire 2 | Average wearing hours across the study period | during 48 weeks | 
| Self-assessment by questionnaire 3 | Reasons and rate for discontinued wear during the study period | during 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myopia control