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Contact Lens

Test Arm for Visual Acuity

N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at least 15-minutes after lens insertion at fitting visit
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
Select...
I am between 40 and 70 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at least 15-minutes after lens insertion at fitting visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and at least 15-minutes after lens insertion at fitting visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 more
Secondary outcome measures
Lens Fit Success
Subjective Comfort Scores
Subjective Handling Scores
+1 more

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.

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Who is running the clinical trial?

Johnson & Johnson Vision Care, Inc.Lead Sponsor
217 Previous Clinical Trials
25,552 Total Patients Enrolled
88 Trials studying Visual Acuity
8,776 Patients Enrolled for Visual Acuity
Johnson & Johnson Vision Care, Inc. Clinical TrialStudy DirectorJohnson & Johnson Vision Care, Inc.
45 Previous Clinical Trials
4,435 Total Patients Enrolled
34 Trials studying Visual Acuity
3,805 Patients Enrolled for Visual Acuity
~0 spots leftby Jun 2024
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