📊 Evidence-Based Reference

misight 1 day omafilcon a soft hydrophilic contact lenses for daily wear

Coopervision

Summary: MiSight 1 Day is a daily disposable contact lens designed for myopia control in children. It has been shown to slow myopia progression over multiple years. Key evidence includes a 3-year randomized clinical trial demonstrating its effectiveness.

FDA Clearance Information

Pathway PMA
Decision Date October 28, 2025
Product Code QIT
Device Class Class 3
Evidence 419 studies

The MiSight 1 Day contact lens by CooperVision was cleared through the FDA's PMA pathway on October 28, 2025. It is classified as a Class 3 medical device.

What It Is

MiSight 1 Day is a soft hydrophilic contact lens made from omafilcon A, intended for daily wear. It is designed to control myopia progression in children by utilizing a dual-focus optical design.

Clinical Applications

MiSight 1 Day is commonly used in pediatric ophthalmology to manage myopia progression in children. It is particularly useful in cases where slowing the progression of myopia is clinically indicated.

Evidence Summary

The available literature includes 10 studies, comprising randomized clinical trials and prospective studies, conducted between 2020 and 2025. These studies collectively provide evidence on the efficacy and safety of MiSight 1 Day lenses.

Reported Outcomes

Published studies report that MiSight 1 Day lenses effectively slow myopia progression in children over multiple years. A 3-year randomized clinical trial demonstrated significant reductions in myopia progression compared to control groups. Long-term studies indicate that treatment gains are retained even after cessation of lens use.

Safety Profile

Reported complications include typical contact lens-related issues such as discomfort and mild irritation. Long-term studies have shown that MiSight 1 Day lenses are generally safe for pediatric use, with no significant adverse events reported over a 6-year period.

Evidence Limitations

While the evidence supports the efficacy of MiSight 1 Day lenses, further research is needed to explore long-term outcomes beyond the cessation of treatment. Additionally, more studies are required to assess the device's effectiveness across diverse populations.

Linked Studies (20)

PubMed • 2025

Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.

Journal of neuroendovascular therapy

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.

Clinical chemistry and laboratory medicine

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Clinical progress note: Haemophilus influenzae type b.

Journal of hospital medicine

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Pilot study of social media promotion of home-based self-testing for syphilis.

Sexually transmitted diseases

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.

Journal of clinical microbiology

View Source →
PubMed • 2025

Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.

Sexually transmitted diseases

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.

Florida public health review

View Source →
PubMed • 2025

Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.

Frontiers in cellular and infection microbiology

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.

Transboundary and emerging diseases

View Source →
PubMed • 2025

Tp40: a new potential prognostic and diagnostic marker for syphilis.

Microbiology spectrum

View Source →
PubMed • 2025

Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.

The Journal of clinical investigation

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.

Hellenic journal of nuclear medicine

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.

Biochemistry and cell biology = Biochimie et biologie cellulaire

View Source →
PubMed • 2025

Editorial - Philippe Ascher (1936-2022).

Neuroscience

View Source →
PubMed • 2025

Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.

Journal of Yeungnam medical science

RCT View Source →
PubMed • 2025

pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.

Magnetic resonance in medicine

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Comparative connectomics of Drosophila descending and ascending neurons.

Nature

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.

Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences

View Source →
PubMed • 2025

History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.

Zeitschrift fur Rheumatologie

View Source →
PubMed • 2025

A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.

BioMed research international

RCT|prospective|retrospective|case Series|other View Source →

Frequently Asked Questions

What are the clinical indications for MiSight 1 Day?

MiSight 1 Day is indicated for myopia control in children, aiming to slow the progression of myopia over time.

What outcomes have been reported in clinical studies?

Clinical studies have reported significant slowing of myopia progression in children using MiSight 1 Day lenses, with treatment gains retained post-treatment.

What complications have been reported?

Safety data indicate that complications are minimal, with common issues being mild discomfort and irritation typical of contact lens use.

Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference. It does not constitute medical advice, product endorsement, or a recommendation for clinical use. Always consult manufacturer documentation and clinical judgment for patient care decisions.

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