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Soft Contact Lens

MiSight 1 Day Contact Lenses for Near-sightedness

N/A
Recruiting
Led By William Gleason, OD
Research Sponsored by Coopervision, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 8 and 12 years of age inclusive at the time of enrollment
Free of ocular disease or abnormalities (including any corneal scar)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial is meant to study the safety of a new type of contact lens among the people it is intended for.

Who is the study for?
This trial is for children aged 8-12 with near-sightedness, who can wear contact lenses for about 10 hours a day and have good overall eye health. They must not have severe dry eyes, infections, or diseases affecting the eyes and must be able to handle lenses properly.Check my eligibility
What is being tested?
The study tests the safety of MiSight 1 Day disposable soft contact lenses in young patients within the US. It aims to confirm that these lenses are safe for daily use among kids who meet specific vision criteria.See study design
What are the potential side effects?
Potential side effects may include discomfort while wearing the contacts, possible allergic reactions to lens material or solutions used with them, and an increased risk of eye infections if proper hygiene isn't followed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 8 and 12 years old.
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My eyes are healthy and free from any diseases or scars.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Microbial Keratitis (MK)
Secondary outcome measures
Incidence of loss of best-corrected visual acuity
Incidence of non-infectious infiltrative keratitis
Incidence of peripheral infiltrative keratitis/non-infectious ulcers

Trial Design

1Treatment groups
Experimental Treatment
Group I: MiSight 1 DayExperimental Treatment1 Intervention
MiSight 1 Day

Find a Location

Who is running the clinical trial?

Coopervision, Inc.Lead Sponsor
156 Previous Clinical Trials
11,469 Total Patients Enrolled
William Gleason, ODPrincipal InvestigatorForesight Regulatory Strategies
3 Previous Clinical Trials
1,458 Total Patients Enrolled

Media Library

MiSight 1 Day (Soft Contact Lens) Clinical Trial Eligibility Overview. Trial Name: NCT05285527 — N/A
Near-sightedness Research Study Groups: MiSight 1 Day
Near-sightedness Clinical Trial 2023: MiSight 1 Day Highlights & Side Effects. Trial Name: NCT05285527 — N/A
MiSight 1 Day (Soft Contact Lens) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05285527 — N/A
Near-sightedness Patient Testimony for trial: Trial Name: NCT05285527 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age of eligibility for this research beyond 30 years?

"This clinical trial requires that participants are within the 8 to 12 year old age-range. There are 64 studies for individuals younger than 18 and 16 studies targeting those over 65 years of age."

Answered by AI

Are there still opportunities available for individuals to enlist in this research program?

"Affirmative. According to the data provided on clinicaltrials.gov, this experiment is actively seeking participants. It was originally posted on August 15th 2022 and has been updated most recently on September 30th 2022. The research team is looking for 2000 patients from a single site location."

Answered by AI

Could I potentially qualify for this medical research project?

"This medical study seeks 2000 myopic minors aged 8-12. All applicants must have a spherical equivalent refractive error between -0.75D and -4.00D (at the corneal plane), anisometropia ≤ 1.50 D, astigmatism of ≤ -0.75 D, free of ocular abnormalities/diseases including any scarring, capable parent/guardian that consents to their child's de-identified data being used for research purposes, possess or obtain eyeglasses with 20/40 vision or better prior to dispensing contact lenses, best corrected visual acuity of at"

Answered by AI

What is the scope of participation in this clinical exploration?

"Yes, the details posted on clinicaltrials.gov verify that this medical study is currently accepting candidates. This trial was first submitted to the website on August 15th 2022 and then last edited on September 30th 2022. 2000 patients are required for enrollment at a single site."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
What site did they apply to?
Advocare Pediatric Eye Physicians
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Contact lens options have recently gotten more limited for me due to a discontinuation of my longstanding brand in my Rx.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
MiSight 1 Day Safety Post-Approval Study
2022. "MiSight 1 Day Safety Post-Approval Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05285527.
All > Myopia
~1500 spots leftby Apr 2027
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