- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05101252
Comparison of a Daily Disposable Multifocal Contact Lens to a Marketed Product
December 15, 2022 updated by: Johnson & Johnson Vision Care, Inc.
This is a single-masked, two-arm, parallel-group, randomized-controlled, dispensing clinical trial to evaluate the visual performance.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
77
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Jacksonville, Florida, United States, 32256
- Stam & Associates Eye Care
-
Longwood, Florida, United States, 32779
- Sabal Eye Care
-
-
Georgia
-
Roswell, Georgia, United States, 30076
- Visual Eyes
-
-
Kansas
-
Pittsburg, Kansas, United States, 66762
- Kannarr Eye Care
-
-
Michigan
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Bloomfield Township, Michigan, United States, 48301
- Birmingham Vision Care
-
-
New York
-
New York, New York, United States, 10022
- Eye Associates of New York
-
-
Ohio
-
Granville, Ohio, United States, 43023
- Procare Vision Centers
-
-
Rhode Island
-
Warwick, Rhode Island, United States, 028888
- West Bay Eye Associates
-
-
Texas
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Tyler, Texas, United States, 75703
- Tyler Eye Associates
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Potential subjects must satisfy all the following criteria to be enrolled in the study:
- Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- Appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Be at least 40 years of age and not greater than 70 years of age at the time of consent.
- Own a wearable pair of spectacles if required for their distance vision.
- Be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 6 hours per wear day, for 1 month or more duration).
- Either already be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".
- The subject's distance spherical equivalent refraction must be in the range of -1.25 D to -3.75 D or +1.25 D to +3.75 D in each eye.
- The subject's refractive cylinder must be ≤0.75 D in each eye.
- The subject's ADD power must be in the range of +0.75 D to +2.50 D.
The subject must have distance best corrected visual acuity of 20/20-3 or better in each eye.
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Be currently pregnant or lactating.
- Have any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.
- Have any active or ongoing systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).
- Have any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.).
- Have a history of amblyopia, strabismus or binocular vision abnormality.
- Use of any of the following medications within 1 week prior to enrollment: oral retinoid, oral tetracyclines, anticholinergics, oral phenothiazines, oral/inhaled corticosteroids. See Table 9.1 for further examples.
- Use of any ocular medication, with the exception of rewetting drops.
- Have a history of herpetic keratitis.
- Have a history of irregular cornea.
- Have a history of pathological dry eye.
- Have Participated in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
- Be and employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
- Have any known hypersensitivity or allergic reaction to non-preserved rewetting drop solutions or sodium fluorescein.
- Have clinically significant (Grade 3 or greater) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.
- Have any current ocular infection or inflammation.
- Have any current ocular abnormality that may interfere with contact lens wear.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: TEST Lens
Eligible subjects who are habitual soft contact lens wearers will be randomized to the TEST Lens sequence for the duration of the study.
|
TEST Lens
|
Experimental: CONTROL Lens
Eligible subjects who are habitual soft contact lens wearers will be randomized to the CONTROL Lens sequence for the duration of the study.
|
CONTROL Lens
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Binocular logMAR Visual Acuity
Time Frame: 1-Week Follow-up
|
Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition.
At distance (4 meters), VA is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts; while near (40 cm) and intermediate (64 cm) assessments were made using reduced Guillon-Poling charts.
Letter-by-letter results calculated the visual performance score for each chart read.
LogMAR scores closer to zero, or below zero, indicate a better visual acuity.
A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
|
1-Week Follow-up
|
CLUE Vision Score
Time Frame: 1-Week Follow-up
|
Subjective vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire.
CLUE is a validated patientreported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65.
Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
The average CLUE vision score for each lens type was reported.
|
1-Week Follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Binocular Distance logMAR Visual Acuity
Time Frame: 1-Week Follow-up
|
Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale at distance (4m) under high luminance high contrast condition assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts.
Letter-by-letter results calculated the visual performance score for each chart read.
LogMAR scores closer to zero, or below zero, indicate a better visual acuity.
A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
|
1-Week Follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 11, 2021
Primary Completion (Actual)
November 29, 2021
Study Completion (Actual)
November 29, 2021
Study Registration Dates
First Submitted
October 8, 2021
First Submitted That Met QC Criteria
October 27, 2021
First Posted (Actual)
November 1, 2021
Study Record Updates
Last Update Posted (Estimate)
January 10, 2023
Last Update Submitted That Met QC Criteria
December 15, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- CR-6468
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health.
Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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