Visual AcuityNCT05258149

Comparison of a Silicone Hydrogel Daily Disposable Multifocal Contact Lens to a Marketed Product

A study testing JJVC Investigational Multifocal Contact Lenses and Dailies Total 1® Multifocal Contact Lenses in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a single-masked, 2×3 crossover, randomized-controlled, dispensing clinical trial to evaluate overall quality of vision. 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 Contact Lenses and Dailies Total 1® Multifocal Contact Lenses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 143 participants
Where: 12 sitesUnited States
Study dates: 18 Feb 2022to 29 Apr 2022
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 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).

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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" (Appendix D).
The subject's distance spherical equivalent refraction (vertex corrected if ≥-4.25 D) must be in the range of -1.25 D to -5.75 D or +0.75 D to +3.25 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.

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.
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, dacryocystorhinostomy, peripheral iridotomy/iridectomy, cataract surgery, retinal surgery, etc.).

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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 section 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 an 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 2 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.

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

ProCare Vision Centers
Granville, Ohio, 43023
Vue Optical Boutique
Jacksonville, Florida, 32205
Stam & Associates Eye Care
Jacksonville, Florida, 32256
Spectrum Eyecare
Jamestown, New York, 14750
Sabal Eye Care
Longwood, Florida, 32779
Maitland Vision Center
Maitland, Florida, 32751
Eye Associates of New York
Manhattan, New York, 10022
Complete Eye Care of Medina
Medina, Minnesota, 55340
VisualEyes
Roswell, Georgia, 30076
Botetourt Eyecare, LLC
Salem, Virginia, 30076
Tyler Eye Associates
Tyler, Texas, 75703
Sacco Eye Group
Vestal, New York, 13850

Other trials in United States

About this study

This is a single-masked, 2×3 crossover, randomized-controlled, dispensing clinical trial to evaluate overall quality of vision.

Conditions: Visual Acuity
Being tested: JJVC Investigational Multifocal Contact Lenses, Dailies Total 1® Multifocal Contact Lenses

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

JJVC Investigational Multifocal Contact LensesDevice
TEST
Dailies Total 1® Multifocal Contact LensesDevice
CONTROL

Study groups in NCT05258149
Study group	Role	What they receive
TEST/CONTROL/CONTROL	Experimental	Eligible subjects will be randomized into the sequence TEST/CONTROL/CONTROL. Receives: Device: JJVC Investigational Multifocal Contact Lenses; Device: Dailies Total 1® Multifocal Contact Lenses
CONTROL/TEST/TEST	Experimental	Eligible subjects will be randomized into the sequence CONTROL/TEST/TEST Receives: Device: JJVC Investigational Multifocal Contact Lenses; Device: Dailies Total 1® Multifocal Contact Lenses

What is being measured

The primary outcome is the main question the study is designed to answer.

Clarity of Vision in Dim or Low Lighting
Clarity of vision in dim or low lighting was assessed at the 1-week follow-up during each study period using the individual item: Clarity of vision in dim or low lighting conditions. This item used a 5-point like-rt scale of (1=Excellent, 2=Very good, 3=Good, 4=Fair and 5=Poor). Results were presented as the percentage of subjects' responses in each category by lens. For analysis and summary purposes three categories were used (T2B-Excellent and Very Good, Middle Box-Good and B2B-Fair and Poor). The 1-week follow-up from each study period (1, 2 and 3) were all included in the summary.
Measured: 1-Week Follow-up
Clarity of Vision When Reading in Dim Light
Clarity of vision when reading in dim light was assessed at the 1-week follow-up during each study period using the individual item: Clarity of vision when reading in dim light(e.g., menu or bill in a restaurant). This item used a 5-point like-rt scale of (1=Excellent, 2=Very good, 3=Good, 4=Fair and 5=Poor). Results were presented as the percentage of subjects' responses in each category by lens. For analysis and summary purposes three categories were used (T2B-Excellent and Very Good, Middle Box-Good and B2B-Fair and Poor). The 1-week follow-up from each study period (1, 2 and 3) were all included in the summary.
Measured: 1-Week Follow-up

Secondary outcomes (3)

Clarity of Distance Vision
Clarity of Distance vision was assessed at the 1-week follow-up during each study period using the individual item: Clarity of distance vision (i.e., looking at things that are more than 5 feet away, such as street signs). This item used a 5-point like-rt scale of (1=Excellent, 2=Very good, 3=Good, 4=Fair and 5=Poor). Results were presented as the percentage of subjects' responses in each category by lens. For analysis and summary purposes three categories were used (T2B- Excellent and Very Good, Middle Box-Good and B2B- Fair and Poor). The 1-week follow-up from each study period (1, 2 and 3) were all included in the summary.
Measured: 1-Week Follow-up
Clarity of Intermediate Vision
Clarity of Intermediate vision was assessed at the 1-week follow-up during each study period using the individual item: Clarity of intermediate vision (i.e., looking at things 2-3 feet away, such as your computer screen). This item used a 5-point like-rt scale of (1=Excellent, 2=Very good, 3=Good, 4=Fair and 5=Poor). Results were presented as the percentage of subjects' responses in each category by lens. For analysis and summary purposes three categories were used (T2B-Excellent and Very Good, Middle Box-Good and B2B-Fair and Poor). The 1-week follow-up from each study period (1, 2 and 3) were all included in the summary.
Measured: 1-Week Follow-up
Clarity of Near Vision
Clarity of Near vision was assessed at the 1-week follow-up during each study period using the individual item: Clarity of intermediate vision (i.e., looking at things close up, such as reading a book). This item used a 5-point like-rt scale of (1=Excellent, 2=Very good, 3=Good, 4=Fair and 5=Poor). Results were presented as the percentage of subjects' responses in each category by lens. For analysis and summary purposes three categories were used (T2B-Excellent and Very Good, Middle Box-Good and B2B-Fair and Poor). The 1-week follow-up from each study period (1, 2 and 3) were all included in the summary.
Measured: 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.

18 Feb 202229 Apr 2022

First posted28 Feb 2022
Study start18 Feb 2022
Primary completion29 Apr 2022
Study completion29 Apr 2022

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: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 143 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05258149
Sponsor's protocol ID: CR-6479
Status last verified: Apr 2023
First submitted: 17 Feb 2022
Last updated: 19 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Visual Acuity trials

Study at a glance

From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of a Silicone Hydrogel Daily Disposable Multifocal Contact Lens to a Marketed Product
ClinicalTrials.gov ID: NCT05258149
Acronym / sponsor ID: CR-6479
Conditions: Visual Acuity
Study type: Interventional
Recruitment status: Completed
Enrolment: 143 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 18 Feb 2022 (actual)
Primary completion: 29 Apr 2022 (actual)
Study completion: 29 Apr 2022 (actual)
First posted: 28 Feb 2022 (actual)
Results: Posted 19 May 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a single-masked, 2×3 crossover, randomized-controlled, dispensing clinical trial to evaluate overall quality of vision.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
TEST/CONTROL/CONTROL	Experimental	Device: JJVC Investigational Multifocal Contact Lenses, Device: Dailies Total 1® Multifocal Contact LensesEligible subjects will be randomized into the sequence TEST/CONTROL/CONTROL.
CONTROL/TEST/TEST	Experimental	Device: JJVC Investigational Multifocal Contact Lenses, Device: Dailies Total 1® Multifocal Contact LensesEligible subjects will be randomized into the sequence CONTROL/TEST/TEST

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

Key exclusion criteria (18 listed)

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, dacryocystorhinostomy, peripheral iridotomy/iridectomy, cataract surgery, retinal surgery, etc.).

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 Contact LensesTEST	Device	CONTROL/TEST/TEST, TEST/CONTROL/CONTROL
Dailies Total 1® Multifocal Contact LensesCONTROL	Device	CONTROL/TEST/TEST, TEST/CONTROL/CONTROL

Primary outcome

Clarity of Vision in Dim or Low Lighting
Time frame: 1-Week Follow-up
Clarity of vision in dim or low lighting was assessed at the 1-week follow-up during each study period using the individual item: Clarity of vision in dim or low lighting conditions. This item used a 5-point like-rt scale of (1=Excellent, 2=Very good, 3=Good, 4=Fair and 5=Poor). Results were presented as the percentage of subjects' responses in each category by lens. For analysis and summary purposes three categories were used (T2B-Excellent and Very Good, Middle Box-Good and B2B-Fair and Poor). The 1-week follow-up from each study period (1, 2 and 3) were all included in the summary.
Clarity of Vision When Reading in Dim Light
Time frame: 1-Week Follow-up
Clarity of vision when reading in dim light was assessed at the 1-week follow-up during each study period using the individual item: Clarity of vision when reading in dim light(e.g., menu or bill in a restaurant). This item used a 5-point like-rt scale of (1=Excellent, 2=Very good, 3=Good, 4=Fair and 5=Poor). Results were presented as the percentage of subjects' responses in each category by lens. For analysis and summary purposes three categories were used (T2B-Excellent and Very Good, Middle Box-Good and B2B-Fair and Poor). The 1-week follow-up from each study period (1, 2 and 3) were all included in the summary.

3 secondary outcomes

Clarity of Distance Vision
Time frame: 1-Week Follow-up
Clarity of Intermediate Vision
Time frame: 1-Week Follow-up
Clarity of Near Vision
Time frame: 1-Week Follow-up

Results and safety

Results posted to the registry on 19 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Senofilcon A C3/Delefilcon A/Delefilcon A	70	69
Delefilcon A/Senofilcon A C3/Senofilcon A C3	73	72

Primary outcome: Clarity of Vision in Dim or Low Lighting

Time frame: 1-Week Follow-up. Number. Unit: Percent

Measure	Senofilcon A C3 n = 143	Delefilcon A n = 143
Excellent or Very Good	54.3	43.3
Good	33.3	36.1
Fair or Poor	12.4	20.6

Senofilcon A C3 vs Delefilcon A: Odds Ratio (OR): 1.65 (95% CI 1.10 to 2.46), Generalized Linear Mixed Model

Population analysed: All dispensed subjects regardless of deviation from protocol and completion status.

Primary outcome: Clarity of Vision When Reading in Dim Light

Time frame: 1-Week Follow-up. Number. Unit: Percent

Measure	Senofilcon A C3 n = 143	Delefilcon A n = 143
Excellent or Very Good	46.2	32.2
Good	32.4	34.1
Fair or Poor	21.4	33.6

Senofilcon A C3 vs Delefilcon A: Odds Ratio (OR): 1.88 (95% CI 1.27 to 2.79), Generalized Linear Mixed Model

Population analysed: All dispensed subjects regardless of deviation from protocol and completion status.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout the duration of the study; Approximately 17-21 days per subject.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Senofilcon A C3	0 of 142 (0%)	0 of 142 (0%)	0 of 142
Delefilcon A	0 of 142 (0%)	0 of 142 (0%)	0 of 142

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
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

Related trials for Visual Acuity

Recruiting
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Recruiting
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Evaluation of Approved Contact Lenses (CR-6657)
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Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)
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Active, not recruitingPhase 2
Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
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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.

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 18 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 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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 19 May 2023). 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?

Clarity of Vision in Dim or Low Lighting (time frame: 1-Week Follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05258149.

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 19 May 2023.