NCT01729208

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 20, 2012

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
10 months until next milestone

Results Posted

Study results publicly available

February 24, 2020

Completed
Last Updated

February 24, 2020

Status Verified

February 1, 2020

Enrollment Period

4.5 years

First QC Date

November 14, 2012

Results QC Date

December 19, 2019

Last Update Submit

February 11, 2020

Conditions

Myopia

Keywords

myopia progressionmyopia control

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (7)

  • Number of Participants With Biomicroscopic Findings Greater Than Grade 2

    Baseline

  • Number of Participants With Biomicroscopic Findings Greater Than Grade 2

    12 months

  • Number of Participants With Biomicroscopic Findings

    24 months

  • Number of Participants With Biomicroscopic Findings Greater Than Grade 2.

    36 months

  • Incidence of Adverse Events

    12 months

  • +2 more secondary outcomes

Study Arms (2)

Dual Focus Soft Contact Lens

EXPERIMENTAL

Dual Focus Soft Contact Lens

Device: Dual Focus Soft Contact Lens

Single Vision Soft Contact Lens

PLACEBO COMPARATOR

Single Vision Soft Contact Lens

Device: Single Vision Soft Contact Lens

Interventions

Dual Focus Soft Contact LensDEVICE
Dual Focus Soft Contact Lens
Single Vision Soft Contact LensDEVICE
Single Vision Soft Contact Lens

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Waterloo School of Optometry

Waterloo, Ontario, N2L 3G1, Canada

Location

University of Minho Clinical & Experiment Optometry Research Lab

Braga, 4710-057, Portugal

Location

National University of Singapore Faculty of Medicine

Singapore, 117597, Singapore

Location

Aston University Ophthalmic Research Group

Birmingham, B4 7ET, United Kingdom

Location

Related Publications (3)

  • Chamberlain P, Hammond DS, Bradley A, Arumugam B, Richdale K, McNally J, Hunt C, Young G. Eye growth and myopia progression following cessation of myopia control therapy with a dual-focus soft contact lens. Optom Vis Sci. 2025 May 1;102(5):353-358. doi: 10.1097/OPX.0000000000002244. Epub 2025 Mar 24.

    PMID: 40132119DERIVED

  • 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.

    PMID: 35086120DERIVED

  • 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.

    PMID: 31343513DERIVED

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Paul Chamberlain
Organization
CooperVision Inc.
PChamberlain@coopervision.com
925 730-6754

Study Officials

  • José Manuel González-Méijome

    University of Minho

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2012

First Posted

November 20, 2012

Study Start

November 1, 2012

Primary Completion

May 1, 2017

Study Completion

May 1, 2019

Last Updated

February 24, 2020

Results First Posted

February 24, 2020

Record last verified: 2020-02

Locations

SG(1)GB(1)CA(1)PT(1)