ClinicalTrials.gg
CompletedNCT06864858Updated Sep 25, 2026Results posted

Clinical Evaluation of Two Cosmetic Contact Lenses

An interventional study of etafilcon A with PVP with cosmetic pattern contact lens and 1-DAY ACUVUE® DEFINE® with LACREON®, FRESH Honey in Visual Acuity, sponsored by Johnson & Johnson Vision Care, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Johnson & Johnson Vision Care, Inc. (part of Johnson & Johnson) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Randomized
Ages
18 Years to 39 Years
Sex
All
01

Study summary

This is a single visit, single-masked, non-dispensing, randomized, controlled, 2×2 bilateral crossover study to evaluate visual acuity.

02

Conditions studied

  • Visual Acuity
03

In context

Lead sponsor

Johnson & Johnson Vision Care, Inc. is the lead sponsor of 221 studies on the registry; 1 is open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 103 (93%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 39 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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

  1. Read, understand, and sign the STATEMENT OF and receive a fully executed copy of the form.
  2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
  3. Be between 18 and 39 (inclusive) years of age at the time of screening.
  4. Be a current soft contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week over the last 30 days by self-report.
  5. 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.
  6. The subject's refractive cylinder must be less than or equal to 0.75 D (inclusive) in each eye.
  7. Have spherical best corrected visual acuity of 20/25 or better in each eye.

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

  1. Be currently pregnant or lactating.
  2. Have any systemic disease (eg, Sjögren's Syndrome), allergies, infectious disease (eg, hepatitis, tuberculosis), contagious diseases (eg, ), 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 investigator's discretion).
  3. Use of systemic medications (eg, chronic use) that are known to interfere with contact lens wear (at the investigator's discretion).
  4. Have any previous, or planned (during the study), ocular surgery (eg, radial keratotomy, PRK, LASIK, etc.).
  5. Have any previous history or signs of a contact lens-related corneal inflammatory event (eg, past peripheral ulcer or round peripheral scar), or any other ocular abnormality that would contraindicate contact lens wear (at the investigator's discretion).
  6. Have participated in any contact lens or lens care product clinical trial within seven (7) days prior to study enrollment.
  7. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.
  8. Have 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 investigator's discretion).
  9. Have any (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.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
53 participants (actual)

Study arms

  • Experimental
    Test Lens/Control Lens

    Eligible subjects will be randomized into the Test Lens/Control Lens sequence, to wear the Test Lens followed by the Control Lens in a bilateral fashion, with a washout period of 5-minutes between wear periods.

    Device: etafilcon A with PVP with cosmetic pattern contact lens · Device: 1-DAY ACUVUE® DEFINE® with LACREON®, FRESH Honey

  • Experimental
    Control Lens/Test Lens

    Eligible subjects will be randomized into the Control Lens/Test Lens sequence, to wear the Control Lens followed by the Test Lens in a bilateral fashion, with a washout period of 5-minutes between wear periods.

    Device: etafilcon A with PVP with cosmetic pattern contact lens · Device: 1-DAY ACUVUE® DEFINE® with LACREON®, FRESH Honey

Interventions

  • Deviceetafilcon A with PVP with cosmetic pattern contact lens

    Test Lens

  • Device1-DAY ACUVUE® DEFINE® with LACREON®, FRESH Honey

    Control Lens

06

What researchers measure

Primary outcomes

  1. Distance Monocular logMAR Visual Acuity

    Distance Monocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. Visual acuity is 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.

    Time frame: Fitting Evaluation

07

Results

Posted May 29, 2026

Participant flow

Period 1
Participant flow — Period 1
MilestoneTest (Etafilcon A)/Control (Etafilcon A)Control (Etafilcon A)/Test (Etafilcon A)
Started2627
Completed2627
Not completed00
Period 2
Participant flow — Period 2
MilestoneTest (Etafilcon A)/Control (Etafilcon A)Control (Etafilcon A)/Test (Etafilcon A)
Started2627
Completed2627
Not completed00

Outcome measures

PrimaryDistance Monocular logMAR Visual Acuity

Distance Monocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. Visual acuity is 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.

Time frame:
Fitting Evaluation
Reported as:
Mean · logMAR
Distance Monocular logMAR Visual Acuity
logMARTest (Etafilcon A)Control (Etafilcon A)
Distance Monocular logMAR Visual Acuity-0.159 ± 0.0665-0.157 ± 0.0740
Statistical analysis
  • Test (Etafilcon A) vs Control (Etafilcon A) · Linear Mixed Model · Least-square mean: -0.002 · 95% CI -0.013 to 0.008

Adverse events

Collected over Throughout the duration of the study; approximately 1 day per subject.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Test (Etafilcon A)0/53 (0%)0/53 (0%)0/53 (0%)
Control (Etafilcon A)0/53 (0%)0/53 (0%)0/53 (0%)

Baseline characteristics

All subjects dispensed at least one study contact lens.

Age, Continuous
Age, Continuous(Years)Overall Reporting Group
Mean31.1 ± 5.36
Sex: Female, Male
Sex: Female, Male(Participants)Overall Reporting Group
Female40
Male13
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Overall Reporting Group
American Indian or Alaska Native0
Asian4
Native Hawaiian or Other Pacific Islander0
Black or African American0
White49
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)Overall Reporting Group
United States53
08

Study locations

1 site
  • Maitland Vision Center - North Orlando Ave
    Maitland, Florida 32751, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: 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

Data sharing details ↗ · yoda.yale.edu

10

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT06864858
Responsible party
Sponsor
First posted
Mar 7, 2025
Start date
Mar 30, 2025
Primary completion
May 5, 2025
Completion
May 5, 2025
Results posted
May 29, 2026
Last update
Sep 25, 2026

Study contacts

Johnson & Johnson Vision Care, Inc. Clinical Trial
study director · Johnson & Johnson Vision Care, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion