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Contact Lens
Multifocal Toric Contact Lenses for Visual Acuity
N/A
Waitlist Available
Research Sponsored by Johnson & Johnson Vision Care, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be at least 40 and not more than 70 years of age at the time of screening
Be older than 18 years old
Must not have
Currently use ocular medication (with the exception of rewetting drops)
Have had any previous, or have any planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, cataract surgery, retinal surgery, etc.)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at least 15-minutes after lens insertion at fitting visit
Awards & highlights
No Placebo-Only Group
Summary
This trial will involve participants visiting three times to evaluate how well they can see. It will be an open-label study, meaning both the participants and researchers will know the treatment being given.
Who is the study for?
This trial is for people aged 40-70 who currently wear soft contact lenses and need extra help for reading (presbyopia). They must have good distance vision with glasses if needed, a specific range of nearsightedness or farsightedness, and mild astigmatism. Participants should be able to follow the study's instructions but can't join if they've had eye surgery, certain diseases that affect lens wear, are pregnant or breastfeeding, or have used excluded medications.
What is being tested?
The trial is testing new daily disposable multifocal toric contact lenses designed to improve vision at all distances for people with presbyopia and astigmatism. It's an open-label study where participants will visit three times to assess how well these contacts correct their vision.
What are the potential side effects?
Potential side effects may include discomfort while wearing the lenses, dry eyes, redness or irritation. Since it's a non-drug intervention, systemic side effects are unlikely but handling the lenses improperly could lead to eye infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 40 and 70 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am using eye medication, not including rewetting drops.
Select...
I have not had, nor am I planning to have, any eye surgery.
Select...
I have had eyelid injuries or surgeries that affected my eyelid's position or movement.
Select...
I have a history of lazy eye or crossed eyes.
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I have severe eye issues as graded by a doctor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at least 15-minutes after lens insertion at fitting visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at least 15-minutes after lens insertion at fitting visit
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Absolute Rotation Error
High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuities at distance 4m
High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuities at intermediate distance 64cm
+5 moreSecondary study objectives
Lens Fit Success
Subjective Comfort Scores
Subjective Handling Scores
+1 moreAwards & 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: Test ArmExperimental Treatment1 Intervention
Eligible subjects who are habitual soft contact lens wearers will be fit with the TEST lens in both eyes, to wear the lens for a minimum of 6 hours a day, every day, between visits for approximately 2 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JJVC Investigational Multifocal Toric Contact Lens manufactured in Senofilcon A (C3) material with UV blocker / HEV filter
2024
N/A
~180
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Who is running the clinical trial?
Johnson & Johnson Vision Care, Inc.Lead Sponsor
219 Previous Clinical Trials
25,615 Total Patients Enrolled
90 Trials studying Visual Acuity
8,839 Patients Enrolled for Visual Acuity
Johnson & Johnson Vision Care, Inc. Clinical TrialStudy DirectorJohnson & Johnson Vision Care, Inc.
46 Previous Clinical Trials
4,438 Total Patients Enrolled
35 Trials studying Visual Acuity
3,808 Patients Enrolled for Visual Acuity
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