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An Evaluation of the Effectiveness of Dual Focus Soft Contact Lenses in Slowing Mypoia Progression

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ClinicalTrials.gov Identifier: NCT01729208
Recruitment Status : Completed
First Posted : November 20, 2012
Results First Posted : February 24, 2020
Last Update Posted : February 24, 2020
Sponsor:
Collaborator:
Visioncare Research Ltd.
Information provided by (Responsible Party):
Coopervision, Inc.

Study Description
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Brief Summary:
The purpose of this study is to determine whether a new type of soft contact lens with a unique optical design (dual focus) is effective at slowing the progression of myopia (near-sightedness) in children.

Condition or disease Intervention/treatment Phase
Myopia Device: Dual Focus Soft Contact Lens Device: Single Vision Soft Contact Lens Not Applicable

Detailed Description:
Subjects were randomized to wear test or control soft contact lens to determine whether a new type of soft contact lens with a unique optical design (dual focus) is effective at slowing the progression of myopia (near-sightedness) in children.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicentre Dispensing Clinical Evaluation of MiSight® Lenses
Actual Study Start Date : November 2012
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Dual Focus Soft Contact Lens
Dual Focus Soft Contact Lens
 Device: Dual Focus Soft Contact Lens
Placebo Comparator: Single Vision Soft Contact Lens
Single Vision Soft Contact Lens
 Device: Single Vision Soft Contact Lens


Outcome Measures
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Primary Outcome Measures :
  1. Change in Refractive Error Relative to Baseline [ Time Frame: 12 months ]
    Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 12 months, relative to baseline.

  2. Change in Refractive Error Relative to Baseline [ Time Frame: 24 months ]
    Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 24 months, relative to baseline.

  3. Change in Refractive Error Relative to Baseline [ Time Frame: 36 months ]
    Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 36 months, relative to baseline.

  4. Change in Axial Length Relative to Baseline [ Time Frame: 12 months ]
    Mean change in axial length measurement, in millimeters at 12 months, relative to baseline.

  5. Change in Axial Length Relative to Baseline [ Time Frame: 24 months ]
    Mean change in axial length measurement, in millimeters at 24 months, relative to baseline.

  6. Change in Axial Length Relative to Baseline [ Time Frame: 36 months ]
    Mean change in axial length measurement, in millimeters at 36 months, relative to baseline.


Secondary Outcome Measures :
  1. Number of Participants With Biomicroscopic Findings Greater Than Grade 2 [ Time Frame: Baseline ]
    Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).

  2. Number of Participants With Biomicroscopic Findings Greater Than Grade 2 [ Time Frame: 12 months ]
    Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).

  3. Number of Participants With Biomicroscopic Findings [ Time Frame: 24 months ]
    Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).

  4. Number of Participants With Biomicroscopic Findings Greater Than Grade 2. [ Time Frame: 36 months ]
    Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).

  5. Incidence of Adverse Events [ Time Frame: 12 months ]
    Cumulative incidence of adverse events.

  6. Incidence of Adverse Events [ Time Frame: 24 months ]
    Cumulative incidence of adverse events.

  7. Incidence of Adverse Events [ Time Frame: 36 months ]
    Cumulative incidence of adverse events.


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be between 8 and 12 years of age inclusive.
  • Best-corrected visual acuity by manifest refraction of +0.10 logMAR.
  • Spherical Equivalent Refractive Error between -0.75 and -4.00 D
  • inclusive astigmatism: < -0.75 D and anisometropia: < 1.00 D
  • Possess wearable and visually functional eyeglasses.
  • Agree to wear the assigned contact lenses for a minimum of 10 hours per day, - at least 6 days per week, for the duration of the 3 year study.

Exclusion Criteria:

  • Subject has previously or currently wears contact lenses or rigid gas permeable contact lenses, including orthokeratology lenses.
  • Subject is currently or within 30 days prior to this study has been an active participant in another clinical study.
  • Current or prior use of bifocals, progressive addition lenses, atropine, pirenzepine or ANY other myopia control treatment.
  • Regular use of ocular medications (prescription or over-the-counter), artificial tears, or wetting agents.
  • Current use of systemic medications which may significantly affect contact lens wear, tear film production, pupil size, accommodation or refractive state.
  • A known allergy to fluorescein, benoxinate, proparacaine or tropicamide.
  • Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction.
  • Any ocular, systemic or neuro-developmental conditions that could influence refractive development.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01729208


Locations
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Canada, Ontario
University of Waterloo School of Optometry
Waterloo, Ontario, Canada, N2L 3G1
Portugal
University of Minho Clinical & Experiment Optometry Research Lab
Braga, Portugal, 4710-057
Singapore
National University of Singapore Faculty of Medicine
Singapore, Singapore, 117597
United Kingdom
Aston University Ophthalmic Research Group
Birmingham, United Kingdom, B4 7ET
Sponsors and Collaborators
Coopervision, Inc.
Visioncare Research Ltd.
Investigators
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Principal Investigator: José Manuel González-Méijome University of Minho
  Study Documents (Full-Text)

Documents provided by Coopervision, Inc.:
Study Protocol  [PDF] July 26, 2012
Statistical Analysis Plan  [PDF] April 30, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT01729208    
Other Study ID Numbers: CVI08008
First Posted: November 20, 2012    Key Record Dates
Results First Posted: February 24, 2020
Last Update Posted: February 24, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Coopervision, Inc.:
myopia progression
myopia control
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases