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Contact Lens

MiSight 1 Day Contact Lenses for Nearsightedness

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
Free of ocular disease or abnormalities (including any corneal scar)
Be between 8 and 12 years of age inclusive at the time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial will test the effectiveness of the MiSight 1 Day lens in reducing myopia (nearsightedness) in children in the real world.

Who is the study for?
This trial is for children aged 8-12 with near-sightedness, having a specific range of vision error and good overall health. They must be willing to wear contact lenses daily for about 10 hours, follow the study's schedule for 4 years, and not have any eye diseases or conditions that could interfere with contact lens use.Check my eligibility
What is being tested?
The MiSight 1 Day contact lens is being tested against Proclear 1 day lenses to confirm its effectiveness in reducing myopia in kids when used in everyday life. The study will monitor changes over one year post-treatment.See study design
What are the potential side effects?
While not explicitly listed, potential side effects may include discomfort while wearing the lenses, redness or irritation of the eyes, dry eyes, allergic reactions to lens material or solutions used with them.

Eligibility Criteria

Inclusion Criteria

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

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
Mean difference in axial length change from baseline
Mean difference in cycloplegic SERE change from baseline
Mean difference in rate of axial length - Part 2 study
+1 more
Secondary outcome measures
Percentage of subjects with no appreciable myopic progression
Visual symptoms and the effects on activities of daily living

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: MiSight 1 dayExperimental Treatment1 Intervention
MiSight 1 day
Group II: Proclear 1 dayActive Control1 Intervention
Proclear 1 day

Find a Location

Who is running the clinical trial?

Coopervision, Inc.Lead Sponsor
156 Previous Clinical Trials
12,969 Total Patients Enrolled
William Gleason, ODPrincipal InvestigatorForesight Regulatory Strategies, Inc. (FRS)
3 Previous Clinical Trials
2,958 Total Patients Enrolled

Media Library

MiSight 1 Day (Contact Lens) Clinical Trial Eligibility Overview. Trial Name: NCT05285553 — N/A
Near-sightedness Research Study Groups: MiSight 1 day, Proclear 1 day
Near-sightedness Clinical Trial 2023: MiSight 1 Day Highlights & Side Effects. Trial Name: NCT05285553 — N/A
MiSight 1 Day (Contact Lens) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05285553 — N/A

Frequently Asked Questions

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

Is this experiment open to individuals over the age of 25?

"The age requirements for participants in this clinical trial are rather specific; potential patients must be between 8 and 12 years of age."

Answered by AI

How many people are engaging in this clinical endeavor?

"This investigation requires 900 consenting individuals that match the mentioned criteria. Participants can come to either New England College of Optometry in Boston or Cornea & Contact Lens Institute of Minnesota in Edina, two esteemed locations for this trial."

Answered by AI

To whom is this experimental program available?

"This clinical trial requires myopic participants aged between 8 and 12 to join. With 900 spots available, the study is actively recruiting a sizeable cohort of patients."

Answered by AI

What is the scope of this medical experiment, in terms of number and type of locations?

"Currently, 5 trial sites are recruiting participants for this clinical study. These locations include Boston, Edina and Granville as well as other nearby medical centres; thus it is important to pick the nearest site in order to reduce any inconvenience caused by travel."

Answered by AI

Are enlistments still being taken for this clinical trial?

"Clinicaltrials.gov reveals that this clinical trial, first advertised on June 25th 2022, is currently searching for participants with its most recent update taking place August 1st 2022."

Answered by AI
~555 spots leftby Jun 2027