Back to search results

MiSight 1 Day Post-Approval Study for Myopia

This study is testing the MiSight 1 Day contact lens to see how well it slows down the worsening of myopia (nearsightedness) in children. It also looks at how stable these results are after treatment stops. You might be able to join if you are between 8 and 12 years old and have nearsightedness within a specific range. The study will compare MiSight 1 Day to another contact lens called Proclear 1 day. Researchers will measure changes in your eye's prescription and length over three years to see if MiSight 1 Day is effective. After that, all participants will wear Proclear 1 day for one year to see if the benefits last. The current recruitment status is unclear.

Study design
This is a randomized, controlled study where neither you nor the study staff will know which contact lens you are receiving (double-masked). It plans to include 900 participants.
What's involved
You would wear either MiSight 1 Day or Proclear 1 day contact lenses for three years, followed by one year of wearing Proclear 1 day lenses.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for three years while wearing study lenses, and then for an additional year after switching to Proclear 1 day lenses.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05285553

MiSight 1 Day Post-Approval Study for Effectiveness and Visual Symptoms

Active, Not Recruiting
NAAges 8–12InterventionalTreatment
CooperVision, Inc.
~900 participants
Updated 2026-07-08 on ClinicalTrials.gov
What's tested:MiSight 1 DayProclear 1 day

At a glance

Recruiting sites
0 of 30 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean difference in cycloplegic SERE change from baseline
Measured over 3 years
+3 more outcomes measured

Conditions

Myopia

Explore related trials

Myopia

Where it's being run

30 sites across 15 states
Illinois5
Ohio5
Texas4
California3
Florida3
Alabama1
Indiana1
Kansas1

Study leadership

  • Kathryn Richdale · STUDY_CHAIR · CooperVision International Limited (CVIL)

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Exclusion

Acute and subacute inflammation or infection of the anterior chamber of the eye.
Any eye disease, injury, or abnormality that affects the cornea, conjunctiva, or eyelids.
Severe insufficiency of lacrimal secretion (dry eyes).
Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic.
Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses.
Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions.
Any active corneal infection (bacterial, fungal, or viral).
If eyes are red or irritated.
The patient is unable to follow lens handling and wear regimen or unable to obtain assistance to do so. 5. Has history of:
Corneal ulcer, corneal infiltrates, ocular viral or fungal infections or other recurrent ocular infections.
Giant papillary conjunctivitis
Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses
A known allergy to fluorescein, benoxinate, proparacaine or tropicamide.
Corneal hypoesthesia (reduced corneal sensitivity) 6. Keratoconus or an irregular cornea. 7. Strabismus or amblyopia. 8. Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses.

What this trial measures

  • Mean difference in cycloplegic SERE change from baseline3 years

    Mean difference in cycloplegic SERE change from baseline; measured with cycloplegic auto-refraction in Diopters

  • Mean difference in axial length change from baseline3 years

    Mean difference in axial length change from baseline between the MiSight 1 Day group and control lens group, measured in millimeters

  • Mean difference in rate of cycloplegic SERE change - Part 2 study1 year

    Mean difference in rate of cycloplegic SERE change between the Part 1 MiSight 1 Day group and the Part 1 control lens group over one-year post-treatment; measured with cycloplegic auto-refraction in Diopters

  • Mean difference in rate of axial length - Part 2 study1 year

    Mean difference in rate of axial length change between the Part 1 MiSight 1 Day group and Part 1 control lens group over one-year post-treatment.