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Contact Lens

Test Arm 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

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 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

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johnson & Johnson Vision Care, Inc.Lead Sponsor

217 Previous Clinical Trials

25,561 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

Frequently Asked Questions

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

Do I meet the requirements to participate in this clinical study?

"Individuals aged between 40 and 70 with a specified level of visual acuity are eligible for participation in this research study, which aims to enroll approximately 155 participants."

Answered by AI

At how many different venues is this medical investigation currently accessible?

"At present, this medical study is accepting participants at 15 diverse sites. These include Pittsburg, Jacksonville, Longwood and various other cities. Opting for the nearest clinic is advised to reduce travel requirements should you decide to partake in the trial."

Answered by AI

Is the clinical trial open to participants under the age of 50?

"Participants must be between 40 and 70 years old to be eligible for this research study. There are separate trials available for individuals under 18 and those older than 65."

Answered by AI

Are there ongoing efforts to enroll individuals in this research study at the moment?

"Per the details on clinicaltrials.gov, this investigation is presently not seeking new participants. Initially shared on April 22nd, 2024 and most recently revised on April 17th, 2024, it's currently inactive in terms of recruitment. However, there are five alternative studies actively seeking eligible candidates at this time."

Answered by AI

What are the anticipated results that this medical study aims to achieve?

"The primary goal of this investigation, to be evaluated during a 14-day monitoring period, is the assessment of High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuities at a close range of 40cm. Secondary targets encompass evaluating Subjective Comfort Scores through CLUE questionnaire administration post the follow-up phase. The aforementioned questionnaire gauges subjective comfort levels in individuals aged between 18 and 65 who wear soft, disposable contact lenses; it assesses various aspects such as comfort, vision quality, handling ease, and packaging satisfaction. Derived CLUE™ scores are determined utilizing Item Response Theory (IRT), exhibiting a"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of the Clinical Performance of Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses

2024. "Evaluation of the Clinical Performance of Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06377488.

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