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Eleven Years of Menicon Z Night Contact Lens Wear in Reducing Myopia Progression in Children (MCOS11)

Primary Purpose

Myopia, Progressive, Children, Only

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Menicon Z Night
Control
Sponsored by
Menicon Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia, Progressive

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Be 6 to 12 years of age, both ages inclusive
  • A low-to-moderate level of myopia (between 0.75 and 4.00 D) and of astigmatism (≤ 1.00 D)
  • Neophyte contact lens wearer
  • Be successfully fitted with spectacles or orthokeratology contact lenses
  • Be able to achieve, through spherical refraction correction, a logMAR visual acuity of 0.8 or better in each eye
  • Be willing and able to follow the subject instructions and to meet the protocol-specified schedule of follow-up visits
  • White European ethnicity

Exclusion Criteria:

  • Systemic or ocular disease affecting ocular health
  • Use of any systemic or topical medications that could affect ocular physiology or contact lens performance
  • Any lid or anterior segment abnormalities for which contact lens wear could be contraindicated
  • CCLRU grade ≥ 2 for any given anterior segment ocular clinical signs
  • Aphakic, amblyopic, and atopic individuals
  • Refractive astigmatism ≥ ½ spherical refraction
  • Previous contact lens wear

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Menicon Z Night

    Control

    Arm Description

    The experimental arm consist of a group of Menicon Z Night orthokeratology contact lens wearers

    The active comparator arm consist of a control group of distance, single-vision glasses and contact lens wearers

    Outcomes

    Primary Outcome Measures

    Axial length
    To compare axial length growth of white European myopic children wearing Menicon Z Night orthokeratology contact lenses to a control group of distance, single-vision glasses and soft contact lens wearers. Measurements of axial length were taken with the Zeiss IOLMaster (Carl Zeiss Jena GmbH, Jena, Germany). Three separate measurements of axial length were recorded per subject and per visit, and a mean obtained.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 10, 2021
    Last Updated
    March 17, 2021
    Sponsor
    Menicon Co., Ltd.
    Collaborators
    Universidad Europea de Madrid, Clinica novovision
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04806711
    Brief Title
    Eleven Years of Menicon Z Night Contact Lens Wear in Reducing Myopia Progression in Children
    Acronym
    MCOS11
    Official Title
    Eleven Years of Menicon Z Night Contact Lens Wear in Reducing Myopia Progression in Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    March 1, 2007 (Actual)
    Primary Completion Date
    March 1, 2018 (Actual)
    Study Completion Date
    March 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Menicon Co., Ltd.
    Collaborators
    Universidad Europea de Madrid, Clinica novovision

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To compare axial length growth of white European myopic children wearing Menicon Z Night orthokeratology contact lenses to a control group of distance, single-vision glasses and contact lenses over an 11-year period.
    Detailed Description
    This prospective, controlled, parallel, longitudinal study compared the axial length growth of white European myopic children wearing Menicon Z Night orthokeratology contact lenses to a control group of distance, single-vision glasses and or distance, single-vision soft contact lenses over an 11-year period.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myopia, Progressive, Children, Only

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Prospective, controlled, parallel, longitudinal
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Menicon Z Night
    Arm Type
    Experimental
    Arm Description
    The experimental arm consist of a group of Menicon Z Night orthokeratology contact lens wearers
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    The active comparator arm consist of a control group of distance, single-vision glasses and contact lens wearers
    Intervention Type
    Device
    Intervention Name(s)
    Menicon Z Night
    Intervention Description
    Menicon Z Night orthokeratology contact lenses were used to assess their efficacy in reducing myopia progression in children
    Intervention Type
    Device
    Intervention Name(s)
    Control
    Intervention Description
    Distance, single-vision glasses were used as a control
    Primary Outcome Measure Information:
    Title
    Axial length
    Description
    To compare axial length growth of white European myopic children wearing Menicon Z Night orthokeratology contact lenses to a control group of distance, single-vision glasses and soft contact lens wearers. Measurements of axial length were taken with the Zeiss IOLMaster (Carl Zeiss Jena GmbH, Jena, Germany). Three separate measurements of axial length were recorded per subject and per visit, and a mean obtained.
    Time Frame
    11 years

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Gender Eligibility Description
    White European
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Be 6 to 12 years of age, both ages inclusive A low-to-moderate level of myopia (between 0.75 and 4.00 D) and of astigmatism (≤ 1.00 D) Neophyte contact lens wearer Be successfully fitted with spectacles or orthokeratology contact lenses Be able to achieve, through spherical refraction correction, a logMAR visual acuity of 0.8 or better in each eye Be willing and able to follow the subject instructions and to meet the protocol-specified schedule of follow-up visits White European ethnicity Exclusion Criteria: Systemic or ocular disease affecting ocular health Use of any systemic or topical medications that could affect ocular physiology or contact lens performance Any lid or anterior segment abnormalities for which contact lens wear could be contraindicated CCLRU grade ≥ 2 for any given anterior segment ocular clinical signs Aphakic, amblyopic, and atopic individuals Refractive astigmatism ≥ ½ spherical refraction Previous contact lens wear

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    22729437
    Citation
    Santodomingo-Rubido J, Villa-Collar C, Gilmartin B, Gutierrez-Ortega R. Myopia control with orthokeratology contact lenses in Spain: refractive and biometric changes. Invest Ophthalmol Vis Sci. 2012 Jul 31;53(8):5060-5. doi: 10.1167/iovs.11-8005.
    Results Reference
    result
    PubMed Identifier
    27767354
    Citation
    Santodomingo-Rubido J, Villa-Collar C, Gilmartin B, Gutierrez-Ortega R, Sugimoto K. Long-term Efficacy of Orthokeratology Contact Lens Wear in Controlling the Progression of Childhood Myopia. Curr Eye Res. 2017 May;42(5):713-720. doi: 10.1080/02713683.2016.1221979. Epub 2016 Oct 21.
    Results Reference
    result

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    Eleven Years of Menicon Z Night Contact Lens Wear in Reducing Myopia Progression in Children

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