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

A Prospective, Randomization, Double-blind Study to Evaluate the Efficacy and Safety of Multifocal Soft Contact Lens in Myopia Control

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

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: soft contact lens

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 Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Tzu-Hsun Tsai M.D.
  • Taipei, Taiwan, 105
    • Ken-Kuo Lin M.D.
  • Taoyuan, Taiwan, 333
    • Jiahn-Shing Lee M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 15 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group A; 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; Group A Group B
Other: Group B; 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; Group A Group B

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Largan Medical Co., Ltd.
• Collaborators: National Taiwan University Hospital; Chang Gung Memorial Hospital
• Investigators: Study Chair: Tzu-Hsun Tsai, M.D., National Taiwan University Hospital; Principal Investigator: Tzu-Hsun Tsai, M.D., National Taiwan University Hospital; Principal Investigator: Chao-Wen Lin, M.D., National Taiwan University Hospital; Principal Investigator: Ken-Kuo Lin, M.D., Taipei Chang Gung Memorial hospital; Principal Investigator: Jiahn-Shing Lee, M.D., Chang Gung Memorial Hospital; Principal Investigator: Chiun-Ho Hou, M.D., Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): March 5, 2020

Study Registration Dates

• First Submitted: January 21, 2018
• First Submitted That Met QC Criteria: January 21, 2018
• First Posted (Actual): January 29, 2018

Study Record Updates

• Last Update Posted (Actual): March 12, 2020
• Last Update Submitted That Met QC Criteria: March 10, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Myopia control
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: LMO00-CL-DM-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No