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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)
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have recent or ongoing eye inflammation or infection.
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I have an eye condition affecting my cornea, conjunctiva, or eyelids.
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My cornea is less sensitive to touch, and I am not aphakic.
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I suffer from severe dry eyes.
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I do not have an active infection in my eye.

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
163 Previous Clinical Trials
11,796 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
~1243 spots leftby Apr 2027
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