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

NCT05285553 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2025-08-17

No results posted yet for this study

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.

Conditions

  • Myopia

Interventions

DEVICE

MiSight 1 Day

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

DEVICE

Proclear 1 day

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.

Sponsors & Collaborators

  • CooperVision, Inc.

    lead INDUSTRY

Principal Investigators

  • William Gleason, OD · Foresight Regulatory Strategies, Inc. (FRS)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-25
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05285553 on ClinicalTrials.gov