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Not yet recruitingNCT07845721Updated Sep 29, 2026

Using Contact Lenses and Spectacle Lenses as Myopia Interventions.

An interventional study of Test Spectacle Lens & Contact Lens and Control Spectacle Lens & Contact Lens in Myopia, sponsored by CooperVision International Limited (CVIL). Not yet recruiting at 2 sites in 2 countries. Open to participants aged 11 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by CooperVision International Limited (CVIL) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
11 Years to 17 Years
Sex
All
01

Study summary

Effect of alternating contact lenses and spectacles for myopia control.

02

Conditions studied

  • Myopia

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03

Who can participate

Ages eligible
11 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Are aged 11 to 17 years (inclusive);
  • Have successfully completed the 4-year MiSight® Analysis of Progression (MAP) Study;
  • Are established soft contact lens wearers (including myopia control contact lens designs);
  • Have read and signed the study consent or assent form, as appropriate for their age;
  • Have a parent or legal guardian who has read and signed the Parent/Guardian Information Sheet (PIS) and Consent Form;
  • Are willing and able to follow study instructions and maintain the appointment schedule;
  • Are willing to wear the study contact lenses for 10 hours/day and 5 days per week as an ideal target while participating;
  • Require a spherical contact lens power correction between -0.50 and -6.00 D;
  • Have astigmatism not exceeding 2.00 DC in each eye by subjective refraction;
  • Have best-corrected visual acuity of 0.10 logMAR (approx. 20/25 Snellen) or better in each eye;
  • Have ocular health findings (biomicroscopy) that do not contraindicate contact lens wear;
  • Continue to demonstrate acceptable fit and handling with the study contact lenses.

Exclusion criteria

Exclusion Criteria:

  • Are participating in any concurrent clinical or interventional study;
  • Have worn rigid gas-permeable (including orthokeratology) contact lenses within the previous 30 days;
  • Have used atropine concentrations above 0.01% for myopia control in the previous 30 days;
  • Are extended-wear contact lens users (i.e., sleep in their lenses);
  • Have best-corrected visual acuity worse than 0.10 logMAR in either eye;
  • Have any current or evolving ocular or systemic condition that could affect visual function, ocular growth, or contact lens wear;
  • Have any clinically significant corneal or conjunctival staining with sodium fluorescein, or other ocular findings contraindicating contact lens wear;
  • Are using systemic or topical medications known or expected to affect pupil size, tear production, accommodation, refractive state, or any study outcome variable;
  • Have a history of ocular surgery, keratoconus, or other forms of irregular cornea, or are aphakic;
  • Have diagnosed accommodative and/or binocular vision anomalies, including amblyopia, strabismus, or nystagmus;
  • Have known sensitivity or allergy to any of the diagnostic agents used in the study;
  • Have any systemic condition that, in the opinion of the investigator, may influence study outcomes or contraindicate soft contact lens wear, including pregnancy;
  • Are a child of an employee of either clinical site directly involved in the study.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
58 participants (estimated)

Study arms

  • Experimental
    Test Group

    Participants will wear Test Spectacle Lens \& Contact Lenses

    Device: Test Spectacle Lens & Contact Lens

  • Experimental
    Control Group

    Participants will wear Control Spectacle Lens \& Contact Lenses

    Device: Control Spectacle Lens & Contact Lens

Interventions

  • DeviceTest Spectacle Lens & Contact Lens

    Participants will wear contact lenses for a target of 10 hours a day, 5 days per week and test spectacle lenses for remaining waking hours.

  • DeviceControl Spectacle Lens & Contact Lens

    Participants will wear contact lenses for a target of 10 hours a day, 5 days per week and control spectacle lenses for remaining waking hours.

05

What researchers measure

Primary outcomes

  1. Change in axial length (AXL, mm) over 12 months

    Time frame: Over 12 months

06

Study locations

2 sites
  • Centre for Ocular Research & Education (CORE) School of Optometry & Vision Science University of Waterloo
    Waterloo, Ontario N2L 3Gi, Canada
    • Jill Woods · Contact · jwoods@uwaterloo.ca · 1-519 888 4567 ext 436743
    • Jill Woods · Principal investigator
    • Deborah Jones · Principal investigator
  • Aston University
    Birmingham, B4 7ET, United Kingdom
07

Registry details

Key details

Study ID
NCT07845721
Lead sponsor
CooperVision International Limited (CVIL)
Collaborators
SightGlass Vision, Inc.
Responsible party
Sponsor
First posted
Sep 29, 2026
Start date
Sep 2026 (estimated)
Primary completion
Feb 2028 (estimated)
Completion
Feb 2028 (estimated)
Last update
Sep 29, 2026

Study contacts

Baskar Arumugam, PhD
Contact
barumugam@coopervision.com
1(925) 353-8468
Baskar Arumugam, PhD
study chair · CooperVision, Inc.
Debbbie Laughton
study chair · SightGlass Vision, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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