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MyopiaNCT05285527

MiSight 1 Day Safety Post-Approval Study

A study testing MiSight 1 Day in people with Myopia, run by CooperVision, Inc. at 50 sites in 2 countries.

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 safety of daily disposable soft contact lens wear among the intended patient population for the MiSight 1 Day lens in the US. 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
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,400 participants
Where
50 sitesin 2 countries
Study dates
15 Aug 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

  • Be between 8 and 12 years of age inclusive at the time of enrollment.
  • Manifest Refraction - Spherical Equivalent Refractive Error (SERE) at baseline between -0.50 D and -7.00 D inclusive (at the corneal plane).
  • Best-corrected visual acuity by manifest refraction of at least 20/25 bilaterally
  • Free of ocular disease or abnormalities (including any corneal scar)
  • The parent/guardian must be capable of comprehending the nature of the study and consent to the use and release of their child's de-identified health care encounter data to be used for purposes of this study. Assent will be obtained from the child in a manner specified by the IRB.
  • Parent/Guardian must sign the Release of Medical Records associated with the outcomes of interest identified from claims data.
  • 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

  • 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.
Show all 10Show fewer
  • 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.
  • In addition to the labeling contraindications, children who are under medication that would interfere with contact lens wear, or who are using any pharmaceuticals for control of myopia will not be included in the study.

Trial locations and contacts

50 sites in 2 countries.

50 sites in 2 countries

United States47 sites

  • Clarity Vision

    Apex, North Carolina, 27502

  • Texas State Optical

    Beaumont, Texas, 77706

  • Bellaire Family Eye Care

    Bellaire, Texas, 77401

  • University of California, Berkeley University Eye Center

    Berkeley, California, 94720

  • Missouri Eye Consultants - California

    California, Missouri, 65018

  • Little Eyes Pediatric Eye Care

    Carmel, Indiana, 46032

  • Cary Family Eye Care

    Cary, North Carolina, 27519

  • Children's Eye Physicians

    Centennial, Colorado, 80112

  • Centerton Family Eyecare

    Centerton, Arkansas, 72719

  • Chagrin Valley Optometrists, Inc.

    Chagrin Falls, Ohio, 44023

  • Lurie Childrens

    Chicago, Illinois, 60611

  • Lyons Family Eye Care P.C.

    Chicago, Illinois, 60657

  • Drs. McIntyre, Garza, Avila and Jurica, Optometrists

    Corpus Christi, Texas, 78411

  • Golden Vision Cupertino Optometry

    Cupertino, California, 95014

  • Boghossian Vision

    Danville, California, 94506

  • Darien Eye Specialists

    Darien, Illinois, 60561

  • Center for Vision and Learning

    Des Peres, Missouri, 63131

  • Iron Horse Optometric Group

    Dublin, California, 94568

  • Capitol Eye Care Center Optometry

    Fremont, California, 94536

  • Clarkson EyeCare KIDS

    Frisco, Texas, 75034

  • Experts on Sight LLC.

    Gilbert, Arizona, 85297

  • Carillon Vision Care

    Glenview, Illinois, 60025

  • Irvine Eye Physicians and Surgeons Inc

    Irvine, California, 92618

  • Planet Vision Eyecare

    Lake Worth, Florida, 33467

  • Marino Eye Care

    Miami, Florida, 33156

  • Eye Physicians & Surgeons, PC

    Milford, Connecticut, 06460

  • Spectrum Optical, PLLC

    Morgantown, West Virginia, 26505

  • Advocare Pediatric Eye Physicians

    Morristown, New Jersey, 07960

  • Elsa Pao OD, Inc

    Oakland, California, 94607

  • Vision Source Oviedo, INC

    Oviedo, Florida, 32765

  • Pickerington Eye Care

    Pickerington, Ohio, 43147

  • Lone Star Vision Center

    Plano, Texas, 75024

  • Child & Family Eye Care Center

    Pleasant Grove, Utah, 84062

  • Redmond Eye Clinic

    Redmond, Washington, 98052

  • All Eyes on Rockville

    Rockville, Maryland, 20852

  • Broadway Eye Clinic

    Salt Lake City, Utah, 84111

  • Stone Oak Vision Source

    San Antonio, Texas, 78258

  • Perfect Pair Optometry

    San Jose, California, 95118

  • Almaden Family Optometric Center

    San Jose, California, 95120

  • Invision Eye Health

    Sandy City, Utah, 84070

  • Gulf Coast Eye Center

    Sarasota, Florida, 34239

  • Dau Family Eye Care

    St. Johns, Florida, 32259

  • Nittany Eye Associates, LLC

    State College, Pennsylvania, 16801

  • Bronx Eye Associates

    The Bronx, New York, 10467

  • Wellesley Vision Group at Optical Design

    Wellesley, Massachusetts, 02482

  • Weston Contact Lens Institute LLC

    Weston, Florida, 33331

  • Colonial Eye Care

    Williamsburg, Virginia, 23185

Other trials in United States

Canada3 sites

  • Dr. Kit Guan & Associates

    Markham, Ontario, L3R3P9

  • Abbey Eye Care

    Oakville, Ontario, L6M5A9

  • Optometry Professional Corporation

    Toronto, Ontario, M2N 3A1

Other trials in Canada

About this study

The purpose of this post-approval study is to confirm the safety of daily disposable soft contact lens wear among the intended patient population for the MiSight 1 Day lens in the US.

Read the detailed description

This prospective post-approval study of safety in a US study population is to confirm the safety of MiSight 1 day lenses. Consecutive subjects receiving the MiSight 1 Day lens, who meet the inclusion criteria, will be prospectively offered to participate in the study. Additionally, safety data from the MiSight 1 Day Post-Approval Study for Effectiveness and Visual Symptoms (PAS001) will be used to supplement this safety study.

Conditions
Myopia
Being tested
MiSight 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

    Subjects will wear MiSight 1 day lenses for three years.

Study groups in NCT05285527
Study groupRoleWhat they receive
MiSight 1 DayExperimentalMiSight 1 Day
Receives: Device: MiSight 1 Day

What is being measured

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

  1. Incidence of Microbial Keratitis (MK)

    Incidence of Microbial Keratitis (MK) ≥ 1 mm

    Measured: 3 years

Secondary outcomes (3)

  1. Incidence of peripheral infiltrative keratitis/non-infectious ulcers

    Incidence of peripheral infiltrative keratitis/non-infectious ulcers ≤ 1 mm

    Measured: 3 years

  2. Incidence of non-infectious infiltrative keratitis

    Incidence of non-infectious infiltrative keratitis ≤ 1 mm

    Measured: 3 years

  3. Incidence of loss of best-corrected visual acuity

    Incidence of loss of best-corrected visual acuity ≥ 2 lines for any adjudicated adverse event.

    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 start15 Aug 2022
  3. Primary completion2 Mar 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05285527
Sponsor's protocol ID
PAS002
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 in people with Myopia, run by CooperVision, Inc. at 50 sites in 2 countries.

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 8 inclusion and 10 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 50 sites in United States, Canada. 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?

Incidence of Microbial Keratitis (MK) (time frame: 3 years). 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 NCT05285527.

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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