Visual AcuityNCT04534764

Evaluation of Visual Performance of Two Types of Cosmetic Contact Lenses

A study testing etafilcon A with cosmetic pattern and 1-Day Acuvue DEFINE Vivid Style in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site 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 visit, brand-masked, non-dispensing, 2×2 bilateral crossover study. Each subject will be bilaterally fitted with one of the two test articles in each of the study periods in a random order with a 5-minute washout period in between study lenses. Read more about this study

Who is it for?: Ages 18 to 39 yearsHealthy volunteers can take part
Conditions the study is for: Visual Acuity
What is being tested?: etafilcon A with cosmetic pattern and 1-Day Acuvue DEFINE Vivid Style
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteUnited States
Study dates: 31 Jul 2020to 12 Aug 2020
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 18 to 39 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Potential subjects must satisfy all of the following criteria to be enrolled in the study:
The subject must 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.
Subjects between 18 and 39 (inclusive) years of age at the time of screening
Be a current soft contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week over the last month by self-report.
The subject must be willing to be photographed and/or video-taped.

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The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 D to -6.00 D (inclusive) in each eye
The subject's refractive cylinder must be less than or equal to 0.75 D (inclusive) in each eye.
Have spherical best corrected visual acuity of 20/25 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:
Currently pregnant or lactating
Any systemic disease (eg, Sjögren's Syndrome), allergies, infectious disease (eg, hepatitis, tuberculosis), contagious immunosuppressive diseases (eg, HIV), autoimmune disease (eg rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study (at the investigators discretion).
Use of systemic medications (eg, chronic steroid use) that are known to interfere with contact lens wear (at the investigators discretion)
Any previous, or planned (during the study) ocular surgery (eg, radial keratotomy, PRK, LASIK, etc.)
Participation in any contact lens or lens care product clinical trial within seven (7) days prior to study enrollment

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Employee or family members of clinical site (eg, Investigator, Coordinator, Technician).
Any 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, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion (at the investigators discretion).
Clinically significant (Grade 3 or 4 on FDA scale) tarsal abnormalities, bulbar injection, corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.

Trial locations and contacts

1 site in 1 country.

United States1 site

Maitland Vision Center
Maitland, Florida, 32751

Other trials in United States

About this study

Conditions: Visual Acuity
Being tested: etafilcon A with cosmetic pattern, 1-Day Acuvue DEFINE Vivid Style

What participants receive

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

etafilcon A with cosmetic patternDevice
TEST
1-Day Acuvue DEFINE Vivid StyleDevice
CONTROL

Study groups in NCT04534764
Study group	Role	What they receive
TEST/CONTROL	Experimental	Eligible subjects that are habitual soft contact lens wearers will be randomized into lens wear sequence (Test/Control) Receives: Device: etafilcon A with cosmetic pattern; Device: 1-Day Acuvue DEFINE Vivid Style
CONTROL/TEST	Experimental	Eligible subjects that are habitual soft contact lens wearers will be randomized into lens wear sequence (Control/Test) Receives: Device: etafilcon A with cosmetic pattern; Device: 1-Day Acuvue DEFINE Vivid Style

What is being measured

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

Distance Monocular Visual Acuity (logMAR)
Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters) under high luminance low contrast and low luminance high contrast lighting conditions 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.
Measured: 5 min post lens insertion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Jul 202012 Aug 2020

First posted1 Sep 2020
Study start31 Jul 2020
Primary completion12 Aug 2020
Study completion12 Aug 2020

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: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04534764
Sponsor's protocol ID: CR-6060
Status last verified: Aug 2021
First submitted: 11 Aug 2020
Last updated: 1 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Visual Performance of Two Types of Cosmetic Contact Lenses
ClinicalTrials.gov ID: NCT04534764
Acronym / sponsor ID: CR-6060
Conditions: Visual Acuity
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 31 Jul 2020 (actual)
Primary completion: 12 Aug 2020 (actual)
Study completion: 12 Aug 2020 (actual)
First posted: 1 Sep 2020 (actual)
Results: Posted 1 Sep 2021

Clinical summary

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

Study design

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

Arm	Type	Receives
TEST/CONTROL	Experimental	Device: etafilcon A with cosmetic pattern, Device: 1-Day Acuvue DEFINE Vivid StyleEligible subjects that are habitual soft contact lens wearers will be randomized into lens wear sequence (Test/Control)
CONTROL/TEST	Experimental	Device: etafilcon A with cosmetic pattern, Device: 1-Day Acuvue DEFINE Vivid StyleEligible subjects that are habitual soft contact lens wearers will be randomized into lens wear sequence (Control/Test)

Who may qualify

Ages: 18 to 39 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Potential subjects must satisfy all of the following criteria to be enrolled in the study:

Key exclusion criteria (9 listed)

Potential subjects who meet any of the following criteria will be excluded from participating in the study:

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
etafilcon A with cosmetic patternTEST	Device	CONTROL/TEST, TEST/CONTROL
1-Day Acuvue DEFINE Vivid StyleCONTROL	Device	CONTROL/TEST, TEST/CONTROL

Primary outcome

Distance Monocular Visual Acuity (logMAR)
Time frame: 5 min post lens insertion
Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters) under high luminance low contrast and low luminance high contrast lighting conditions 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.

Results and safety

Results posted to the registry on 1 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test/Control	18	18
Control/Test	17	17

Primary outcome: Distance Monocular Visual Acuity (logMAR)

Time frame: 5 min post lens insertion. Mean (Standard Deviation). Unit: logMAR

Measure	Test n = 35	Control n = 35
High Luminance Low Contrast	-0.016 (0.1083)	-0.001 (0.1046)
High Luminance High Contrast	-0.171 (0.0857)	-0.151 (0.0852)
Low Luminance High Contrast	0.016 (0.1008)	0.007 (0.0814)

Test vs Control: Least Square Mean Difference: -0.016 (95% CI -0.039 to 0.006), Mixed Models Analysis
Test vs Control: Least Square Mean Difference: 0.009 (95% CI -0.014 to 0.031), Mixed Models Analysis

Population analysed: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.

Adverse events

Time frame: Throughout the duration of the study. Approximately 1 day per subject.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test	0 of 35 (0%)	0 of 35 (0%)	0 of 35
Control	0 of 35 (0%)	0 of 35 (0%)	0 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
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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Active, not recruiting
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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A study testing etafilcon A with cosmetic pattern and 1-Day Acuvue DEFINE Vivid Style in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site 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 9 inclusion and 9 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 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 1 Sep 2021). 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?

Distance Monocular Visual Acuity (logMAR) (time frame: 5 min post lens insertion). 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 NCT04534764.

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 1 Sep 2021.