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

A Multicentre Dispensing Clinical Evaluation of MiSight® Lenses

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Dual Focus Soft Contact Lens; Device: Single Vision Soft Contact Lens

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 Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • University of Waterloo School of Optometry
• Portugal
  • Braga, Portugal, 4710-057
    • University of Minho Clinical & Experiment Optometry Research Lab
• Singapore
  • Singapore, Singapore, 117597
    • National University of Singapore Faculty of Medicine
• United Kingdom
  • Birmingham, United Kingdom, B4 7ET
    • Aston University Ophthalmic Research Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dual Focus Soft Contact Lens	Device: Dual Focus Soft Contact Lens
Placebo Comparator: Single Vision Soft Contact Lens	Device: Single Vision Soft Contact Lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Refractive Error Relative to Baseline	Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 12 months, relative to baseline.	12 months
Change in Refractive Error Relative to Baseline	Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 24 months, relative to baseline.	24 months
Change in Refractive Error Relative to Baseline	Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 36 months, relative to baseline.	36 months
Change in Axial Length Relative to Baseline	Mean change in axial length measurement, in millimeters at 12 months, relative to baseline.	12 months
Change in Axial Length Relative to Baseline	Mean change in axial length measurement, in millimeters at 24 months, relative to baseline.	24 months
Change in Axial Length Relative to Baseline	Mean change in axial length measurement, in millimeters at 36 months, relative to baseline.	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Biomicroscopic Findings Greater Than Grade 2	Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).	Baseline
Number of Participants With Biomicroscopic Findings Greater Than Grade 2	Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).	12 months
Number of Participants With Biomicroscopic Findings	Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).	24 months
Number of Participants With Biomicroscopic Findings Greater Than Grade 2.	Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).	36 months
Incidence of Adverse Events	Cumulative incidence of adverse events.	12 months
Incidence of Adverse Events	Cumulative incidence of adverse events.	24 months
Incidence of Adverse Events	Cumulative incidence of adverse events.	36 months

Collaborators and Investigators

• Sponsor: Coopervision, Inc.
• Collaborators: Visioncare Research Ltd.
• Investigators: Principal Investigator: José Manuel González-Méijome, University of Minho

Publications and helpful links

General Publications

• Chamberlain P, Bradley A, Arumugam B, Hammond D, McNally J, Logan NS, Jones D, Ngo C, Peixoto-de-Matos SC, Hunt C, Young G. Long-term Effect of Dual-focus Contact Lenses on Myopia Progression in Children: A 6-year Multicenter Clinical Trial. Optom Vis Sci. 2022 Mar 1;99(3):204-212. doi: 10.1097/OPX.0000000000001873.
• Chamberlain P, Peixoto-de-Matos SC, Logan NS, Ngo C, Jones D, Young G. A 3-year Randomized Clinical Trial of MiSight Lenses for Myopia Control. Optom Vis Sci. 2019 Aug;96(8):556-567. doi: 10.1097/OPX.0000000000001410.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2012
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: November 14, 2012
• First Submitted That Met QC Criteria: November 14, 2012
• First Posted (Estimate): November 20, 2012

Study Record Updates

• Last Update Posted (Actual): February 24, 2020
• Last Update Submitted That Met QC Criteria: February 11, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: myopia progression; myopia control
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CVI08008

Drug and device information, study documents

• 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