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MyopiaNCT05285553

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

A study testing MiSight 1 Day and Proclear 1 day in people with Myopia, run by CooperVision, Inc. at 30 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this post-approval study is to confirm the effectiveness of the MiSight 1 Day lens in clinical practices within the US and to assess the stability of the myopia reduction over one-year post-treatment. Read more about this study

Who is it for?
Ages 8 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Myopia
What is being tested?
MiSight 1 Day and Proclear 1 day
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
900 participants
Where
30 sitesUnited States
Study dates
25 Jun 2022to 30 Jun 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Informed Consent and Assent have been completed
  • Be between 8 and 12 years of age inclusive at the time of enrollment.
  • Manifest Refraction - Spherical Equivalent Refractive Error (SERE) at baseline between -0.75 D and -4.00 D inclusive (at the corneal plane) in each eye
  • Best-corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye.
  • Anisometropia: ≤ 1.50D SERE.
  • Astigmatism: ≤ 0.75 D
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  • Free of ocular disease or abnormalities (including any corneal scar)
  • Currently have good general health.
  • Agree to accept the lens as assigned by the randomization.
  • Be capable of comprehending the nature of the study and be willing and able to adhere to the instructions set forth in this protocol.
  • Ability to comply with study procedures, including high and low (sub-study only) contrast high and low (sub-study only) lighting visual acuity, axial length, and cycloplegic auto-refraction measurements taken for both eyes.
  • Able to maintain the visit schedule.
  • Willingness to participate in the trial for 4 years.
  • Interested in wearing contact lenses for approximately 10 hours per day and 6 days per week.
  • Possesses, or obtains prior to dispensing, wearable and visually functional (20/40 or better) eyeglasses.

Who cannot join

  • Current or prior use of any pharmaceuticals or other methods for control of myopia, such as bifocals, progressive addition lenses, orthokeratology, atropine, pirenzepine or any other myopia control treatment.
  • Use of any systemic or topical ocular medications or over-the-counter artificial tears which might interfere with contact lens wear, pupil size, accommodation or refractive state, or require the lenses to be removed during the day.
  • Previously worn or currently wears rigid gas permeable contact lenses, including orthokeratology lenses
  • Has any of the following specific contraindications to MiSight 1 Day lenses at Baseline Visit:
  • 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.
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  • 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.
  • 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)
  • Keratoconus or an irregular cornea.
  • Strabismus or amblyopia.
  • Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses.

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

United States30 sites

  • Athens Eye Care

    Athens, Ohio, 45701

  • Texas State Optical

    Beaumont, Texas, 77706

  • Factoria Eye Clinic

    Bellevue, Washington, 98006

  • University of Alabama School of Optometry

    Birmingham, Alabama, 35233

  • Clinical Optics Research Lab at IU School of Optometry

    Bloomington, Indiana, 47406

  • New England College of Optometry

    Boston, Massachusetts, 02115

  • Virginia Pediatric Eye Care

    Chesapeake, Virginia, 23320

  • SoLo Eye Care & Eyewear Gallery

    Chicago, Illinois, 60608

  • Illinois College of Optometry

    Chicago, Illinois, 60616

  • Ohio State University

    Columbus, Ohio, 43210

  • Chicago College of Optometry

    Downers Grove, Illinois, 60515

  • Cornea and Contact Lens Institute

    Edina, Minnesota, 55436

  • Marshall B. Ketchum University Southern California College of Optometry

    Fullerton, California, 92831

  • Carillon Vision Care

    Glenview, Illinois, 60025

  • ProCare Vision Center, Inc.

    Granville, Ohio, 43023

  • University of Houston College of Optometry

    Houston, Texas, 77204

  • Vision Source EyeCare

    Kansas City, Missouri, 64111

  • Vision One Eyecare

    Katy, Texas, 77450

  • Vision Solutions Optometry Inc

    La Mesa, California, 91942

  • Southern College of Optometry

    Memphis, Tennessee, 38104

  • Miamisburg Vision Care

    Miamisburg, Ohio, 45342

  • Coan Eye Care and Optical Boutique

    Ocoee, Florida, 34761

  • Utah Eye Centers

    Ogden, Utah, 84403

  • Kannarr Eye Care

    Pittsburg, Kansas, 66762

  • Lone Star Vision

    Plano, Texas, 75024

  • Eye Care Professionals

    Powell, Ohio, 43065

  • Paje Optometric

    Santa Ana, California, 92704

  • Brain Vision Institute

    Schaumburg, Illinois, 60194

  • West Broward Eyecare Associates

    Tamarac, Florida, 33321

  • Bright Eyes Family Vision Care

    Tampa, Florida, 33626

Other trials in United States

About this study

The purpose of this post-approval study is to confirm the effectiveness of the MiSight 1 Day lens in clinical practices within the US and to assess the stability of the myopia reduction over one-year post-treatment.

Read the detailed description

This study is a multicenter, parallel-group, controlled, double-masked (subject and investigator), randomized clinical trial with a total duration of four years.

Part 1 of this study will study the effectiveness of MiSight 1 Day in slowing myopia progression over three years in a US population. Subjects in Part 1 will wear MiSight 1 Day lenses or Proclear 1 day lenses.

Part 2 will study the stability of the effectiveness result over a one-year post-treatment period. All subjects in Part 2 will wear Proclear 1 day lenses. Subjects and investigators will remain masked from Part 1.

Conditions
Myopia
Being tested
MiSight 1 Day, Proclear 1 day
Medical subject headings
Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MiSight 1 DayDevice

    Part 1 of the study - subjects will be randomized to wear MiSight 1 Day for three years.

  • Proclear 1 dayDevice

    Part 1 of the study - subjects will be randomized to wear Proclear 1 day for three years.

    Part 2 of the study - All the subjects will wear Proclear 1 day lenses for one year.

Study groups in NCT05285553
Study groupRoleWhat they receive
MiSight 1 dayExperimentalMiSight 1 day
Receives: Device: MiSight 1 Day
Proclear 1 dayActive comparatorProclear 1 day
Receives: Device: Proclear 1 day

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean difference in cycloplegic SERE change from baseline

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

    Measured: 3 years

  2. Mean difference in axial length change from baseline

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

    Measured: 3 years

  3. Mean difference in rate of cycloplegic SERE change - Part 2 study

    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

    Measured: 1 year

  4. Mean difference in rate of axial length - Part 2 study

    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.

    Measured: 1 year

Secondary outcomes (2)

  1. Percentage of subjects with no appreciable myopic progression

    Percentage of subjects with no appreciable myopic progression (-0.25D change or less)

    Measured: 3 years

  2. Visual symptoms and the effects on activities of daily living

    Visual symptoms and the effects on activities of daily living are measured using a validated PRO Measure

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2022
  2. Study start25 Jun 2022
  3. Primary completion30 Jan 2030 (estimated)
  4. Study completion30 Jun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05285553
Sponsor's protocol ID
PAS001/BC
Status last verified
Jul 2026
First submitted
9 Mar 2022
Last updated
8 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing MiSight 1 Day and Proclear 1 day in people with Myopia, run by CooperVision, Inc. at 30 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean difference in cycloplegic SERE change from baseline (time frame: 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05285553.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.

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Clinical Trial NCT05285553 | AzTrials