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

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Dual Focus Soft Contact Lens
Single Vision Soft Contact Lens
Sponsored by
Coopervision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring myopia progression, myopia control

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Waterloo School of Optometry
  • University of Minho Clinical & Experiment Optometry Research Lab
  • National University of Singapore Faculty of Medicine
  • Aston University Ophthalmic Research Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dual Focus Soft Contact Lens

Single Vision Soft Contact Lens

Arm Description

Dual Focus Soft Contact Lens

Single Vision Soft Contact Lens

Outcomes

Primary Outcome Measures

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.
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.
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.
Change in Axial Length Relative to Baseline
Mean change in axial length measurement, in millimeters at 12 months, relative to baseline.
Change in Axial Length Relative to Baseline
Mean change in axial length measurement, in millimeters at 24 months, relative to baseline.
Change in Axial Length Relative to Baseline
Mean change in axial length measurement, in millimeters at 36 months, relative to baseline.

Secondary Outcome Measures

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).
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).
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).
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).
Incidence of Adverse Events
Cumulative incidence of adverse events.
Incidence of Adverse Events
Cumulative incidence of adverse events.
Incidence of Adverse Events
Cumulative incidence of adverse events.

Full Information

First Posted
November 14, 2012
Last Updated
February 11, 2020
Sponsor
Coopervision, Inc.
Collaborators
Visioncare Research Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01729208
Brief Title
An Evaluation of the Effectiveness of Dual Focus Soft Contact Lenses in Slowing Mypoia Progression
Official Title
A Multicentre Dispensing Clinical Evaluation of MiSight® Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
November 2012 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.
Collaborators
Visioncare Research Ltd.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
myopia progression, myopia control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dual Focus Soft Contact Lens
Arm Type
Experimental
Arm Description
Dual Focus Soft Contact Lens
Arm Title
Single Vision Soft Contact Lens
Arm Type
Placebo Comparator
Arm Description
Single Vision Soft Contact Lens
Intervention Type
Device
Intervention Name(s)
Dual Focus Soft Contact Lens
Intervention Type
Device
Intervention Name(s)
Single Vision Soft Contact Lens
Primary Outcome Measure Information:
Title
Change in Refractive Error Relative to Baseline
Description
Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 12 months, relative to baseline.
Time Frame
12 months
Title
Change in Refractive Error Relative to Baseline
Description
Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 24 months, relative to baseline.
Time Frame
24 months
Title
Change in Refractive Error Relative to Baseline
Description
Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 36 months, relative to baseline.
Time Frame
36 months
Title
Change in Axial Length Relative to Baseline
Description
Mean change in axial length measurement, in millimeters at 12 months, relative to baseline.
Time Frame
12 months
Title
Change in Axial Length Relative to Baseline
Description
Mean change in axial length measurement, in millimeters at 24 months, relative to baseline.
Time Frame
24 months
Title
Change in Axial Length Relative to Baseline
Description
Mean change in axial length measurement, in millimeters at 36 months, relative to baseline.
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Number of Participants With Biomicroscopic Findings Greater Than Grade 2
Description
Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).
Time Frame
Baseline
Title
Number of Participants With Biomicroscopic Findings Greater Than Grade 2
Description
Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).
Time Frame
12 months
Title
Number of Participants With Biomicroscopic Findings
Description
Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).
Time Frame
24 months
Title
Number of Participants With Biomicroscopic Findings Greater Than Grade 2.
Description
Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).
Time Frame
36 months
Title
Incidence of Adverse Events
Description
Cumulative incidence of adverse events.
Time Frame
12 months
Title
Incidence of Adverse Events
Description
Cumulative incidence of adverse events.
Time Frame
24 months
Title
Incidence of Adverse Events
Description
Cumulative incidence of adverse events.
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Manuel González-Méijome
Organizational Affiliation
University of Minho
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Waterloo School of Optometry
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada
Facility Name
University of Minho Clinical & Experiment Optometry Research Lab
City
Braga
ZIP/Postal Code
4710-057
Country
Portugal
Facility Name
National University of Singapore Faculty of Medicine
City
Singapore
ZIP/Postal Code
117597
Country
Singapore
Facility Name
Aston University Ophthalmic Research Group
City
Birmingham
ZIP/Postal Code
B4 7ET
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
35086120
Citation
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.
Results Reference
derived
PubMed Identifier
31343513
Citation
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.
Results Reference
derived

Learn more about this trial

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

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