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

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.

• soft contact lens (Device): Group A Group B

Primary outcomes

• Objective cycloplegic refractive error [48 weeks]: Changes in objective cycloplegic refractive error between the two eyes in 48 weeks
• Axial length [48 weeks]: Changes in axial length between the two eyes in 48 weeks

Secondary outcomes

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

Sex: All, ages: 6 Years to 15 Years, accepts healthy volunteers

Inclusion Criteria:

1. Both genders aged between 6 and 15 years
2. Spherical equivalent refractive error between -1.00D and -10.00D
3. Visual acuity with contact lens of 20/25 or better in each eye
4. Astigmatism less than or equal to 1.50D
5. Anisometropia less than or equal to 1.00D
6. Agree to wear assigned contact lens and able to comply with the study protocol
7. Subjects and/or their legal representatives agree to sign informed consent form

Exclusion Criteria:

1. Eye disease or vision problem that may contraindicate/interfere with contact lens wearing, for example:

   1. Amblyopia
   2. Severe strabismus at investigator's discretion
   3. Pathologically dry eye
   4. Aphakia
   5. Slit lamp findings including but not limited to corneal edema, corneal ulcer, bulbar redness that are more serious than grade 1
   6. Currently ocular infection of any type or inflammation in either eye
   7. Oculomotor nerve palsies
   8. Pupil or lid abnormality in either eye
   9. Severe ocular allergy
   10. Anterior segment infection, inflammation or abnormality
   11. Corneal vascularization greater than 1 mm of penetration
   12. History of herpetic keratitis
2. 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
3. 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
4. Surgically altered eyes (e.g. corneal or refractive surgery, not including stye removal surgery)
5. 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)

• Tzu-Hsun Tsai, M.D., Study chair, National Taiwan University Hospital
• Tzu-Hsun Tsai, M.D., Principal investigator, National Taiwan University Hospital
• Chao-Wen Lin, M.D., Principal investigator, National Taiwan University Hospital
• Ken-Kuo Lin, M.D., Principal investigator, Taipei Chang Gung Memorial Hospital
• Jiahn-Shing Lee, M.D., Principal investigator, Chang Gung Memorial Hospital
• Chiun-Ho Hou, M.D., Principal investigator, Chang Gung Memorial Hospital