MiSight 1 Day Safety Post-Approval Study

July 6, 2026 updated by: CooperVision, Inc.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • Markham, Ontario, Canada, L3R3P9
        • Dr. Kit Guan & Associates
      • Oakville, Ontario, Canada, L6M5A9
        • Abbey Eye Care
      • Toronto, Ontario, Canada, M2N 3A1
        • Optometry Professional Corporation
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • Experts on Sight LLC.
    • Arkansas
      • Centerton, Arkansas, United States, 72719
        • Centerton Family Eyecare
    • California
      • Berkeley, California, United States, 94720
        • University of California, Berkeley University Eye Center
      • Cupertino, California, United States, 95014
        • Golden Vision Cupertino Optometry
      • Danville, California, United States, 94506
        • Boghossian Vision
      • Dublin, California, United States, 94568
        • Iron Horse Optometric Group
      • Fremont, California, United States, 94536
        • Capitol Eye Care Center Optometry
      • Irvine, California, United States, 92618
        • Irvine Eye Physicians and Surgeons Inc
      • Oakland, California, United States, 94607
        • Elsa Pao OD, Inc
      • San Jose, California, United States, 95118
        • Perfect Pair Optometry
      • San Jose, California, United States, 95120
        • Almaden Family Optometric Center
    • Colorado
      • Centennial, Colorado, United States, 80112
        • Children's Eye Physicians
    • Connecticut
      • Milford, Connecticut, United States, 06460
        • Eye Physicians & Surgeons, PC
    • Florida
      • Lake Worth, Florida, United States, 33467
        • Planet Vision Eyecare
      • Miami, Florida, United States, 33156
        • Marino Eye Care
      • Oviedo, Florida, United States, 32765
        • Vision Source Oviedo, INC
      • Sarasota, Florida, United States, 34239
        • Gulf Coast Eye Center
      • St. Johns, Florida, United States, 32259
        • Dau Family Eye Care
      • Weston, Florida, United States, 33331
        • Weston Contact Lens Institute LLC
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Lurie Childrens
      • Chicago, Illinois, United States, 60657
        • Lyons Family Eye Care P.C.
      • Darien, Illinois, United States, 60561
        • Darien Eye Specialists
      • Glenview, Illinois, United States, 60025
        • Carillon Vision Care
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Little Eyes Pediatric Eye Care
    • Maryland
      • Rockville, Maryland, United States, 20852
        • All Eyes on Rockville
    • Massachusetts
      • Wellesley, Massachusetts, United States, 02482
        • Wellesley Vision Group at Optical Design
    • Missouri
      • California, Missouri, United States, 65018
        • Missouri Eye Consultants - California
      • Des Peres, Missouri, United States, 63131
        • Center for Vision and Learning
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Advocare Pediatric Eye Physicians
    • New York
      • The Bronx, New York, United States, 10467
        • Bronx Eye Associates
    • North Carolina
      • Apex, North Carolina, United States, 27502
        • Clarity Vision
      • Cary, North Carolina, United States, 27519
        • Cary Family Eye Care
    • Ohio
      • Chagrin Falls, Ohio, United States, 44023
        • Chagrin Valley Optometrists, Inc.
      • Pickerington, Ohio, United States, 43147
        • Pickerington Eye Care
    • Pennsylvania
      • State College, Pennsylvania, United States, 16801
        • Nittany Eye Associates, LLC
    • Texas
      • Beaumont, Texas, United States, 77706
        • Texas State Optical
      • Bellaire, Texas, United States, 77401
        • Bellaire Family Eye Care
      • Corpus Christi, Texas, United States, 78411
        • Drs. McIntyre, Garza, Avila and Jurica, Optometrists
      • Frisco, Texas, United States, 75034
        • Clarkson EyeCare KIDS
      • Plano, Texas, United States, 75024
        • Lone Star Vision Center
      • San Antonio, Texas, United States, 78258
        • Stone Oak Vision Source
    • Utah
      • Pleasant Grove, Utah, United States, 84062
        • Child & Family Eye Care Center
      • Salt Lake City, Utah, United States, 84111
        • Broadway Eye Clinic
      • Sandy City, Utah, United States, 84070
        • Invision Eye Health
    • Virginia
      • Williamsburg, Virginia, United States, 23185
        • Colonial Eye Care
    • Washington
      • Redmond, Washington, United States, 98052
        • Redmond Eye Clinic
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • Spectrum Optical, PLLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Be between 8 and 12 years of age inclusive at the time of enrollment.
  2. Manifest Refraction - Spherical Equivalent Refractive Error (SERE) at baseline between -0.50 D and -7.00 D inclusive (at the corneal plane).
  3. Best-corrected visual acuity by manifest refraction of at least 20/25 bilaterally
  4. Free of ocular disease or abnormalities (including any corneal scar)
  5. 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.
  6. Parent/Guardian must sign the Release of Medical Records associated with the outcomes of interest identified from claims data.
  7. Interested in wearing contact lenses for approximately 10 hours per day and 6 days per week.
  8. Possesses, or obtains prior to dispensing, wearable and visually functional (20/40 or better) eyeglasses.

Exclusion Criteria:

  1. Acute and subacute inflammation or infection of the anterior chamber of the eye.
  2. Any eye disease, injury, or abnormality that affects the cornea, conjunctiva, or eyelids.
  3. Severe insufficiency of lacrimal secretion (dry eyes).
  4. Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic.
  5. Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses.
  6. Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions.
  7. Any active corneal infection (bacterial, fungal, or viral).
  8. If eyes are red or irritated.
  9. The patient is unable to follow lens handling and wear regimen or unable to obtain assistance to do so.
  10. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MiSight 1 Day
Device: MiSight 1 Day
Subjects will wear MiSight 1 day lenses for three years.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Microbial Keratitis (MK)
Time Frame: 3 years
Incidence of Microbial Keratitis (MK) ≥ 1 mm
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of peripheral infiltrative keratitis/non-infectious ulcers
Time Frame: 3 years
Incidence of peripheral infiltrative keratitis/non-infectious ulcers ≤ 1 mm
3 years
Incidence of non-infectious infiltrative keratitis
Time Frame: 3 years
Incidence of non-infectious infiltrative keratitis ≤ 1 mm
3 years
Incidence of loss of best-corrected visual acuity
Time Frame: 3 years
Incidence of loss of best-corrected visual acuity ≥ 2 lines for any adjudicated adverse event.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CooperVision, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Kathryn Richdale, CooperVision International Limited (CVIL)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 2, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PAS002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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