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

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
soft contact lens
Sponsored by
APP Vision Care Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring myopia control, soft contact lens, eye diseases

Eligibility Criteria

9 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Myopia (SE) between -1.00D to -8.00D
  • Astigmatism less than or equal to 1.75D
  • Myopia progression ≧0.75 D in the past 12 months
  • Best Corrected Visual Acuity (BCVA): 0.9 Snellen or better
  • Willingness to wear contact lens constantly
  • Availability for follow-up for at least 1 year
  • Parent's understanding and acceptance
  • have an acceptable surrogate capable of giving legally authorized consent on behalf of the subject

Exclusion Criteria:

  • Anisometropia greater than 2.00D
  • Presence of ocular disease preventing wear of contact lens
  • Severe ocular or systemic allergies
  • Taking any medication that might have an impact on contact lens wear or that might influence the outcome of the clinical trial
  • Ocular or systemic condition that might affect refractive development
  • Atropine/Pirenzepine treatment for myopia control in the past 1 month
  • Prior use of Ortho-K lenses
  • Dry eye with Schimer Test (basal secretion test) < 5mm/5min or other physical condition that would contraindicate contact lens wear

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Ticon Aspherical Daily Disposable Soft Contact Lens

    Ticon Daily Soft Contact Lens

    Arm Description

    The subject will be requested to wear lens 8 hours a day, 5 days a week at least. The contact lens will be worn and replaced every day. All subjects will be followed for 1 year post device allocation with a brief clinical assessment at 1 day, 1 week, 1, 3, 6, 9, 12 months.

    The subject will be requested to wear lens 8 hours a day, 5 days a week at least. The contact lens will be worn and replaced every day. All subjects will be followed for 1 year post device allocation with a brief clinical assessment at 1 day, 1 week, 1, 3, 6, 9, 12 months.

    Outcomes

    Primary Outcome Measures

    Spherical Equivalent Refraction (SER)
    The change in spherical equivalent refraction (SER) measured by cycloplegic autorefraction over 12 months.

    Secondary Outcome Measures

    Axial Eye Length (AXL)
    The change in axial eye length (AXL) measured over 12 months. Axial length is measured after cycloplegia using optical biometry.

    Full Information

    First Posted
    January 19, 2020
    Last Updated
    January 19, 2020
    Sponsor
    APP Vision Care Inc.
    Collaborators
    National Taiwan University Hospital, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04238897
    Brief Title
    To Evaluate the Efficacy and Safety of Aspherical Soft Contact Lens in Myopia Control
    Official Title
    A Prospective Randomized Control Study to Evaluate the Effect of Ticon Aspherical Daily Disposable Soft Contact Lens on Myopia Control
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    May 4, 2016 (Actual)
    Primary Completion Date
    September 12, 2018 (Actual)
    Study Completion Date
    June 6, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    APP Vision Care Inc.
    Collaborators
    National Taiwan University Hospital, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The objective of this study is to demonstrate that the Ticon Aspherical Daily Disposable Soft Contact Lens could retard myopia progress in youth
    Detailed Description
    This study is designed as a prospective, multicenter, randomized, double blinded, controlled, paired-eye comparison study. At least 60 evaluable subjects with myopia progression ≧ 0.75 D in the past 12 months will be recruited from 2 study sites. The experimental soft contact lens with aspherical design (Ticon Aspherical) will be randomly assigned to either the right eye or the left eye of the subject , then the fellow eye will be assigned a control lens with a single vision distance (SVD) soft contact lens (Ticon). Both lenses will be worn at least 8 hours a day, 5 days a week for 1 year. All lenses will be replaced every day. Brief assessment of the clinical findings will be followed up for one year at 1 day, 1 week, 1, 3, 6, 9, 12 months upon allocation. The primary efficacy outcome is change in spherical equivalent refraction (SER) measured by cycloplegic autorefraction over 12 months. The secondary outcome is change in axial eye length (AXL) measured over 12 months. The secondary outcome measure is used to corroborate any changes in SER

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myopia
    Keywords
    myopia control, soft contact lens, eye diseases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    paired-eye design
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    72 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ticon Aspherical Daily Disposable Soft Contact Lens
    Arm Type
    Experimental
    Arm Description
    The subject will be requested to wear lens 8 hours a day, 5 days a week at least. The contact lens will be worn and replaced every day. All subjects will be followed for 1 year post device allocation with a brief clinical assessment at 1 day, 1 week, 1, 3, 6, 9, 12 months.
    Arm Title
    Ticon Daily Soft Contact Lens
    Arm Type
    Placebo Comparator
    Arm Description
    The subject will be requested to wear lens 8 hours a day, 5 days a week at least. The contact lens will be worn and replaced every day. All subjects will be followed for 1 year post device allocation with a brief clinical assessment at 1 day, 1 week, 1, 3, 6, 9, 12 months.
    Intervention Type
    Device
    Intervention Name(s)
    soft contact lens
    Primary Outcome Measure Information:
    Title
    Spherical Equivalent Refraction (SER)
    Description
    The change in spherical equivalent refraction (SER) measured by cycloplegic autorefraction over 12 months.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Axial Eye Length (AXL)
    Description
    The change in axial eye length (AXL) measured over 12 months. Axial length is measured after cycloplegia using optical biometry.
    Time Frame
    12 months
    Other Pre-specified Outcome Measures:
    Title
    Primary safety Endpoints
    Description
    All dispensed eyes over all follow-up visits. Measured on a scale of 0-4 with 0=no findings and 4=severe findings. Epithelial edema, epithelial microcysts, corneal staining, limbal & bulbar injection, conjunctival abnormalities, corneal neovascularization and infiltrates will be measured.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    9 Years
    Maximum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Myopia (SE) between -1.00D to -8.00D Astigmatism less than or equal to 1.75D Myopia progression ≧0.75 D in the past 12 months Best Corrected Visual Acuity (BCVA): 0.9 Snellen or better Willingness to wear contact lens constantly Availability for follow-up for at least 1 year Parent's understanding and acceptance have an acceptable surrogate capable of giving legally authorized consent on behalf of the subject Exclusion Criteria: Anisometropia greater than 2.00D Presence of ocular disease preventing wear of contact lens Severe ocular or systemic allergies Taking any medication that might have an impact on contact lens wear or that might influence the outcome of the clinical trial Ocular or systemic condition that might affect refractive development Atropine/Pirenzepine treatment for myopia control in the past 1 month Prior use of Ortho-K lenses Dry eye with Schimer Test (basal secretion test) < 5mm/5min or other physical condition that would contraindicate contact lens wear
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tzu-Hsun Tsai, M.D.
    Organizational Affiliation
    National Taiwan University Hospital
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Elizabeth P Shen, M.D.
    Organizational Affiliation
    Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Hsiao-Sang Chu, M.D.
    Organizational Affiliation
    National Taiwan University Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Han-Chih Cheng, M.D.
    Organizational Affiliation
    Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    35737291
    Citation
    Shen EP, Chu HS, Cheng HC, Tsai TH. Center-for-Near Extended-Depth-of-Focus Soft Contact Lens for Myopia Control in Children: 1-Year Results of a Randomized Controlled Trial. Ophthalmol Ther. 2022 Aug;11(4):1577-1588. doi: 10.1007/s40123-022-00536-5. Epub 2022 Jun 23.
    Results Reference
    derived

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

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