Visual AcuityNCT06377488
Evaluation of the Clinical Performance of Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses
A study testing JJVC Investigational Multifocal Toric Contact Lens manufactured in Senofilcon A (C3) material with UV blocker / HEV filter in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 15 sites in United States.
Trial summary
This will be an open-label, 3-visit, single-arm, dispensing clinical trial to evaluate visual acuity. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity
- What is being tested?
- JJVC Investigational Multifocal Toric Contact Lens manufactured in Senofilcon A (C3) material with UV blocker / HEV filter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 15 sitesUnited States
- Study dates
- 22 Apr 2024to 24 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Potential subjects must satisfy all of 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 and not more than 70 years of age at the time of screening.
- 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 for at least 8 hours per day at least two days per week for the past 4 weeks).
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- Be already 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 component of their refraction must be in the range of either -1.25 D to -3.75 D, or +1.25 D to +4.25 D.
- The subject's refractive cylinder must be in the range of -1.00 D to -1.75 D in each eye, with the cylinder axes in the range of either 90°±15° or 180°±15°.
- The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye.
- The subject must have best corrected distance visual acuity of 20/20-3 or better in each eye.
Who cannot join
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- The subject must not:
- Be currently pregnant or lactating.
- By self-report, have any systemic disease (e.g. Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, which are known to interfere with contact lens wear and/or participation in the study.
- Use systemic medications that may interfere with contact lens wear or cause blurred vision. See Section 9.1 for additional details regarding excluded systemic medications.
- Currently use ocular medication (with the exception of rewetting drops).
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- Have any known hypersensitivity or allergic reaction to single use preservative free rewetting drops or sodium fluorescein.
- Have had any previous, or have any planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, cataract surgery, retinal surgery, etc.).
- Have had previous eyelid injuries, surgeries or procedures which are known to have caused abnormal eyelid position or movement, by self-report.
- Have participated in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
- Be an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
- Have a history of amblyopia or strabismus, by self-report.
- Have a history of herpetic keratitis, by self-report.
- Have ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion.
- Have any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA scale.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Birmingham Vision Care
Bloomfield Hills, Michigan, 48301
Mid-State Eye
Clinton, Illinois, 61727
ProCare Vision Centers
Granville, Ohio, 43023
Dr. James Weber & Associates, PA - City Square Blvd
Jacksonville, Florida, 32218
Stam & Associates Eye Care
Jacksonville, Florida, 32256
Omega Vision Center
Longwood, Florida, 32779
Maitland Vision Center - North Orlando Ave
Maitland, Florida, 32751
Center for Ophthalmic and Vision Research/Eye Associates of New York
Manhattan, New York, 10022
Optometry Group, LLC
Memphis, Tennessee, 38111
New River Vision Care
Oak Hill, West Virginia, 25901
Kannarr Eye Care
Pittsburg, Kansas, 66762
Luxe Vision and Optical
Powell, Ohio, 43065
Tyler Eye Associates
Tyler, Texas, 75703
Sacco Eye Group
Vestal, New York, 13850
Dr. David W. Ferris & Associates
Warwick, Rhode Island, 02888
About this study
This will be an open-label, 3-visit, single-arm, dispensing clinical trial to evaluate visual acuity.
- Conditions
- Visual Acuity
- Being tested
- JJVC Investigational Multifocal Toric Contact Lens manufactured in Senofilcon A (C3) material with UV blocker / HEV filter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JJVC Investigational Multifocal Toric Contact Lens manufactured in Senofilcon A (C3) material with UV blocker / HEV filterDevice
Test Lens
| Study group | Role | What they receive |
|---|---|---|
| Test Arm | Experimental | 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. Receives: Device: JJVC Investigational Multifocal Toric Contact Lens manufactured in Senofilcon A (C3) material with UV blocker / HEV filter |
What is being measured
The primary outcome is the main question the study is designed to answer.
HLHC Binocular logMAR Visual Acuities
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. Data from hyperopes and myopes were combined for this outcome since logMAR scores between the two populations are similar.
Measured: 2-Week Follow-up
CLUE Vision Scores
Subjective vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported 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 sphere stratum (Hyperope and Myope) was reported.
Measured: 2-Week Follow-up
Proportion of Eyes With Absolute Rotation Less Than or Equal to 10 Degrees
Absolute rotation was assessed for each subject eye using a slit lamp 15-minutes after lens insertion. Acceptable absolute rotation was dichotomized into a binary response where Y=1 if absolute rotation was less than or equal to 10 degrees and Y=0 otherwise (absolute rotation greater than 10 degrees). The proportion of eyes with absolute rotation less than or equal to 10 degrees was report for each lens.
Measured: 15-minutes after lens insertion
Proportion of Eyes With Rotational Stability Less Than or Equal to 5 Degrees
Rotational Stability was assessed for each subject eye using a slit lamp 15-minutes after lens insertion. Rotational Stability was dichotomized into a binary response where Y=1 if Rotational Stability was less than or equal to 5 degrees and Y=0 otherwise (Rotational Stability greater than 5 degrees). The proportion of eyes with Rotational Stability less than or equal to 5 degrees was report for each lens.
Measured: 15-minutes after lens insertion
Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings
Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 1-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher was reported. Data from the hyperope and myopes group were combined for this outcome since the rate of SFLs grade 3+ is similar for these two populations.
Measured: Up to 2-Week Follow-up
Proportion of Eyes With Unacceptable Lens Fitting
Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope post lens insertion at the 1-week follow-up.
Lens fit was a binary variable where unacceptable lens fit=1 and acceptable lens fit=0. The proportion of eyes with unacceptable lens fit was reported. Data from the hyperope and myopes group were combined for this outcome since lens fitting characteristics are similar for these two populations.
Measured: Up to 2-Week Follow-up
Secondary outcomes (4)
CLUE Vision Scores
Subjective vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported 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 sphere stratum (Hyperope and Myope) was reported.
Measured: 2-Week Follow-up
CLUE Comfort Scores
Subjective comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported 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 comfort scores for each sphere stratum (Hyperope and Myope) were reported.
Measured: 2-Week Follow-up
CLUE Handling Scores
Subjective handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported 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 handling scores for each sphere stratum (Hyperope and Myope) were reported.
Measured: 2-Week Follow-up
Proportion of Subject Achieving Optimal Lens Pair in 4 Lenses or Less.
The number of lenses to achieve the optimal pair for each subject was calculated as the original pair (2) plus all the required modifications to reach the optimal pair. In this study the minimum number of lenses per subject used was 2 where the maximum possible number of lenses used was 10. The data was dichotomized as Y=1 if the subject was able to achieve optimal lens pair in 4 lenses or lenses or less and 0 otherwise. A lens modification was performed if the subject reports unsatisfactory vision or was unable to obtain 20/30 distance visual acuity in both eyes. If the subject reported satisfactory vision with the lenses a modification was not required. However, based upon the investigator's findings on the measured visual acuity and/or over- refraction a modification may have been performed. Data for the hyperope and myope groups were combined for this endpoint since the number of subjects needed to optimize vision is independent of which group a subject belongs to.
Measured: Up to 1-Week Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start22 Apr 2024
- Primary completion24 Jun 2024
- Study completion24 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Visual AcuityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Vision Care, Inc. Clinical Trial, Study director, Johnson & Johnson Vision Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377488
- Sponsor's protocol ID
- CR-6542
- Status last verified
- Oct 2025
- First submitted
- 17 Apr 2024
- Last updated
- 28 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Performance of Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses
- ClinicalTrials.gov ID
- NCT06377488
- Acronym / sponsor ID
- CR-6542
- Conditions
- Visual Acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 22 Apr 2024 (actual)
- Results
- Posted 9 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be an open-label, 3-visit, single-arm, dispensing clinical trial to evaluate visual acuity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test Arm | Experimental | Device: JJVC Investigational Multifocal Toric Contact Lens manufactured in Senofilcon A (C3) material with UV blocker / HEV filterEligible 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Potential subjects must satisfy all of 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 and not more than 70 years of age at the time of screening.
- Own a wearable pair of spectacles if required for their distance vision.
Key exclusion criteria (15 listed)
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Be currently pregnant or lactating.
- By self-report, have any systemic disease (e.g. Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, which are known to interfere with contact lens wear and/or participation in the study.
- Use systemic medications that may interfere with contact lens wear or cause blurred vision. See Section 9.1 for additional details regarding excluded systemic medications.
- Currently use ocular medication (with the exception of rewetting drops).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JJVC Investigational Multifocal Toric Contact Lens manufactured in Senofilcon A (C3) material with UV blocker / HEV filterTest Lens | Device | Test Arm |
Primary outcome
HLHC Binocular logMAR Visual Acuities
Time frame: 2-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. Data from hyperopes and myopes were combined for this outcome since logMAR scores between the two populations are similar.
CLUE Vision Scores
Time frame: 2-Week Follow-up
Subjective vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported 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 sphere stratum (Hyperope and Myope) was reported.
Proportion of Eyes With Absolute Rotation Less Than or Equal to 10 Degrees
Time frame: 15-minutes after lens insertion
Absolute rotation was assessed for each subject eye using a slit lamp 15-minutes after lens insertion. Acceptable absolute rotation was dichotomized into a binary response where Y=1 if absolute rotation was less than or equal to 10 degrees and Y=0 otherwise (absolute rotation greater than 10 degrees). The proportion of eyes with absolute rotation less than or equal to 10 degrees was report for each lens.
Proportion of Eyes With Rotational Stability Less Than or Equal to 5 Degrees
Time frame: 15-minutes after lens insertion
Rotational Stability was assessed for each subject eye using a slit lamp 15-minutes after lens insertion. Rotational Stability was dichotomized into a binary response where Y=1 if Rotational Stability was less than or equal to 5 degrees and Y=0 otherwise (Rotational Stability greater than 5 degrees). The proportion of eyes with Rotational Stability less than or equal to 5 degrees was report for each lens.
Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings
Time frame: Up to 2-Week Follow-up
Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 1-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher was reported. Data from the hyperope and myopes group were combined for this outcome since the rate of SFLs grade 3+ is similar for these two populations.
Proportion of Eyes With Unacceptable Lens Fitting
Time frame: Up to 2-Week Follow-up
Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope post lens insertion at the 1-week follow-up. Lens fit was a binary variable where unacceptable lens fit=1 and acceptable lens fit=0. The proportion of eyes with unacceptable lens fit was reported. Data from the hyperope and myopes group were combined for this outcome since lens fitting characteristics are similar for these two populations.
4 secondary outcomes
CLUE Vision Scores
Time frame: 2-Week Follow-up
CLUE Comfort Scores
Time frame: 2-Week Follow-up
CLUE Handling Scores
Time frame: 2-Week Follow-up
Proportion of Subject Achieving Optimal Lens Pair in 4 Lenses or Less.
Time frame: Up to 1-Week Follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Vision Care, Inc. Clinical Trial study director
Johnson & Johnson Vision Care, Inc.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JJVC Investigational Multifocal Toric Contact Lens manufactured in Senofilcon A (C3) material with UV blocker / HEV filter in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HLHC Binocular logMAR Visual Acuities (time frame: 2-Week Follow-up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2025.