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

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: soft contact lens

• Registration Number: NCT03413085
• Lead Sponsor: Largan Medical Co., Ltd.

Brief Summary

The objective of this study is to investigate the efficacy and safety of soft lens in myopia control.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-01-21
• Study First Submitted QC: 2018-01-21
• Study First Posted: 2018-01-29
• Study Start: 2018-05-02
• Primary Completion: 2019-12-31
• Status Verified: 2020-03
• Study Completion: 2020-03-05
• Last Update Submitted: 2020-03-10
• Last Update Posted: 2020-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	soft contact lens	Intervention name: multifocal soft contact lens/single vision soft contact lens Left eye: multifocal soft contact lens Right eye: single vision soft contact lens
Group B	soft contact lens	Intervention name: multifocal soft contact lens/single vision soft contact lens Left eye: single vision soft contact lens Right eye: multifocal soft contact lens

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Tzu-Hsun Tsai M.D.; 🇨🇳 Taipei, Taiwan

Ken-Kuo Lin M.D.; 🇨🇳 Taipei, Taiwan

Jiahn-Shing Lee M.D.; 🇨🇳 Taoyuan, Taiwan