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Completed

NCT Number: NCT01729208

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

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.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Waterloo School of Optometry, Waterloo, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dual Focus Soft Contact Lens

Device

Single Vision Soft Contact Lens

Device

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Collaborators

  • Visioncare Research Ltd.

Registry information

Official study title

A Multicentre Dispensing Clinical Evaluation of MiSight® Lenses

Important dates

Study start
2012
Primary completion
2017
Study completion
2019
First posted
Nov 20, 2012
Registry last updated
Feb 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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