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Soft Contact Lenses

Contact 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
Must not have
Have undergone refractive error surgery or intraocular surgery
Have any known active ocular disease, allergies and/or infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had surgery to correct my vision or eye surgery.
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I have an active eye disease, allergy, or infection.
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I am currently using atropine for my nearsightedness.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
High contrast, binocular, distance visual acuity
Secondary study objectives
Subjective Vision Quality

Awards & Highlights

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

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.

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Who is running the clinical trial?

Coopervision, Inc.Lead Sponsor
163 Previous Clinical Trials
14,166 Total Patients Enrolled
Lyndon Jones, PhD,FCOptomPrincipal InvestigatorUniversity of Waterloo
1 Previous Clinical Trials
68 Total Patients Enrolled
~16 spots leftby Nov 2025
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