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Soft Contact Lenses

Test Lenses, Then Control Lenses for Near-sightedness

N/A

Recruiting

Led By Lyndon Jones, PhD,FCOptom

Research Sponsored by Coopervision, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Are 8 to 18 years of age inclusive and have full legal capacity to volunteer

Are correctable to a visual acuity of +0.10 logMAR or better (in each eye) with sphero-cylindrical subjective refraction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 days

Awards & highlights

Study Summary

This trial compares two types of contact lenses to see which one works better for vision.

Who is the study for?

This trial is for near-sighted children and teenagers aged 8 to 18 who regularly wear soft contact lenses for distance vision. They must have a prescription between -0.75D to -7.00D, with astigmatism ≤ -0.75D in each eye, and be able to see clearly with corrective lenses. Participants need wearable backup glasses and can't have worn rigid or ortho-keratology lenses recently, nor can they sleep in their lenses or be on atropine treatment.Check my eligibility

What is being tested?

The study aims to compare the performance of two types of daily disposable contact lenses: an investigational silicone hydrogel lens (test) versus a commercially available hydrogel lens (control). Participants will switch between the test and control lenses over one week to assess visual quality.See study design

What are the potential side effects?

Potential side effects from wearing contact lenses typically include discomfort, dry eyes, redness, blurry vision, tearing up, or infection risk if not used properly.

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 18 years old and can legally consent.

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My vision corrects to near perfect with glasses or contacts.

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My eyes are healthy with no scars or diseases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

High contrast, binocular, distance visual acuity

Secondary outcome measures

Subjective Vision Quality

Trial Design

2Treatment groups

Experimental Treatment

Group I: Test Lenses, Then Control LensesExperimental Treatment2 Interventions

Participants will wear the Test Lenses in both eyes for one week and then cross over to the Control Lenses in both eyes for one week.

Group II: Control Lenses, Then Test LensesExperimental Treatment2 Interventions

Participants will wear the Control Lenses in both eyes for one week and then cross over to the Test Lenses in both eyes for one week.

0 / 3Eligibility criteria met

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Who is running the clinical trial?

Coopervision, Inc.Lead Sponsor

155 Previous Clinical Trials

13,799 Total Patients Enrolled

Lyndon Jones, PhD,FCOptomPrincipal InvestigatorUniversity of Waterloo

1 Previous Clinical Trials

60 Total Patients Enrolled

Frequently Asked Questions

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

How many people have enrolled in this clinical examination?

"Affirmative. According to the details provided on clinicaltrials.gov, this medical experiment--which was first submitted on December 11th 2021--is actively recruiting patients. 30 participants are required from a solitary site."

Answered by AI

Are there still opportunities for new patients to join this research experiment?

"Yes, the evidence on clinicaltrials.gov attests to this study's active recruitment of participants. The trial was first posted in December 11th 2022 and has been updated as recently as December 6th 2023. Thus far, 30 patients have enrolled from a single site."

Answered by AI

Is enrollment open for individuals aged 85 and above to participate in this research?

"This trial invites participants aged 8 to 18 years old."

Answered by AI

Is it possible for me to participate in this investigation?

"To qualify for this clinical trial, individuals between the ages of 8 and 18 who are near-sighted can apply. A total of 30 participants will be accepted into the research study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

1 Week Crossover Dispensing Study Between Two Soft Contact Lenses

2023. "1 Week Crossover Dispensing Study Between Two Soft Contact Lenses". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06170658.

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