CClinicalTrials.gg
CompletedNCT06333613Updated Jun 3, 2025Results posted

Evaluation of Acuvue Oasys 1-Day Contact Lenses in New Wearers

An interventional study of ACUVUE OASYS® 1-DAY with HydraLuxe™ TECHNOLOGY (AO1D) in Visual Acuity, sponsored by Johnson & Johnson Vision Care, Inc.. Completed at 5 sites in United States. Open to participants aged 13 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-03.

Sponsored by Johnson & Johnson Vision Care, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Ages
13 Years to 39 Years
Sex
All
01

Study summary

This is a multi-site, bilateral, dispensing, non-randomized, uncontrolled, unmasked, single arm study to evaluate visual acuity in neophytes.

02

Conditions studied

  • Visual Acuity
03

In context

Lead sponsor

Johnson & Johnson Vision Care, Inc. is the lead sponsor of 220 studies on the registry; 2 are open to participants now.

Of its 110 completed or terminated interventional studies of FDA-regulated products, 101 (92%) have results posted.

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

04

Who can participate

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

Inclusion criteria

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

The subject must:

  1. Read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form (For subjects aged 18 and older)
  2. Read (or be read to) and sign the Children's Assent (Information and Assent Form) and receive a fully executed copy of the form. (For subjects aged 13 to 17)
  3. Have parents or legal guardians who must read, understand, and sign the Statement of Informed Consent (Parental Permission Form and Authorization to Use and Disclose Medical Information). (For subjects aged 13 to 17)
  4. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
  5. Be between 13 and 39 (inclusive) years of age at the time of screening.
  6. By self-report, having never worn any type of contact lenses and never attempted to insert contact lenses.
  7. Have a pair of prescription glasses on hand that corrects distance vision, if determined to be required by the investigator.
  8. The magnitude of the cylindrical component of the subject's vertex-corrected distance refraction must be ≤ 0.75 DC in each eye.
  9. Subject must have a vertex corrected distance sphero-cylindrical refraction in the range such that appropriate spherical lens powers are available for correction in both eyes. The spherical lens powers available in this study are:

    a. -1.00 to -6.00 (in 0.25D steps)

  10. Best corrected monocular distance visual acuity must be 20/20-3 or better in each eye.

Exclusion criteria

Exclusion Criteria:

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

The subject must not:

  1. Be currently pregnant or lactating.
  2. Be currently using any ocular medications or have any ocular infection of any type.
  3. By self-report, have any ocular or systemic disease, allergies, or infection, or use medications that the investigator believes might contraindicate or interfere with contact lens wear, or otherwise compromise the study endpoints. See section 9.1 for additional details regarding systemic medications.
  4. Have previously participated in a contact lens, contact lens package, or lens care related clinical trial.
  5. 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.
  6. Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp findings or other corneal, eyelid, or ocular disease or abnormalities that the investigator believes might contraindicate contact lens wear or may otherwise compromise study endpoints (including significant blepharitis, entropion, ectropion, ptosis, chalazia, recurrent styes, pterygium, significant dry eye disease, history of recurrent corneal erosions, aphakia, corneal distortion, herpetic keratitis).
  7. Have a history of strabismus or amblyopia.
  8. Have fluctuations in vision due to clinically significant dry eye or other ocular or systemic conditions.
  9. Have had or have planned (within the study period) any ocular or intraocular surgery or procedures (e.g., PRK, LASIK, IPL, blepharoplasty, etc.)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Test Lens

    Eligible subjects will be fitted bilaterally with the TEST lens for approximately 2 weeks of wear (two 1-week wear periods).

    Device: ACUVUE OASYS® 1-DAY with HydraLuxe™ TECHNOLOGY (AO1D)

Interventions

  • DeviceACUVUE OASYS® 1-DAY with HydraLuxe™ TECHNOLOGY (AO1D)

    Test Lens

06

What researchers measure

Primary outcomes

  1. Incidence (Percentage) of Eyes With Grade 3 or 4 Slit Lamp Findings Related to the Study Lenses

    Slit Lamp Findings (SLFs) 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). SLF assessment was performed on each subject eye at different study visits (Baseline, unscheduled visits, 1-week follow-up, 2-Week Follow-up, and Final Evaluation). The percentage of eyes with SLF of grade 3 or grade 4 was reported.

    Time frame: Up to 2-Week Follow-up

07

Results

Posted Jun 3, 2025

Participant flow

A total of 36 subjects were enrolled in this study. Of those enrolled, 34 subjects were dispensed the study lens, while 1 subject withdrew consent before lens dispensing and 1 subject failed to meet all eligibility criteria. Of those dispensed, 33 subjects completed the study while 1 subject was discontinued.

Participant flow — Overall Study
MilestoneTest (Senofilcon A C3)
Started34
Completed33
Not completed1
Withdrew: Doesn't like wearing contacts1

Outcome measures

PrimaryIncidence (Percentage) of Eyes With Grade 3 or 4 Slit Lamp Findings Related to the Study Lenses

Slit Lamp Findings (SLFs) 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). SLF assessment was performed on each subject eye at different study visits (Baseline, unscheduled visits, 1-week follow-up, 2-Week Follow-up, and Final Evaluation). The percentage of eyes with SLF of grade 3 or grade 4 was reported.

Time frame:
Up to 2-Week Follow-up
Reported as:
Number · Percentage
Incidence (Percentage) of Eyes With Grade 3 or 4 Slit Lamp Findings Related to the Study Lenses
PercentageTest (Senofilcon A C3)
Incidence (Percentage) of Eyes With Grade 3 or 4 Slit Lamp Findings Related to the Study Lenses0

Adverse events

Collected over Throughout the duration of the study; approximately 2-weeks per subject.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Test (Senofilcon A C3)0/34 (0%)0/34 (0%)0/34 (0%)

Baseline characteristics

All subjects dispensed a study lens.

Age, Continuous
Age, Continuous(Years)Test (Senofilcon A C3)
Mean23.1 ± 7.59
Sex: Female, Male
Sex: Female, Male(Participants)Test (Senofilcon A C3)
Female22
Male12
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Test (Senofilcon A C3)
American Indian or Alaska Native0
Asian2
Native Hawaiian or Other Pacific Islander2
Black or African American1
White28
More than one race1
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)Test (Senofilcon A C3)
United States34
08

Study locations

5 sites
  • Scripps Poway Eyecare & Optometry
    San Diego, California 92131, United States
  • Omega Vision Center
    Longwood, Florida 32779, United States
  • Maitland Vision Center - North Orlando Ave
    Maitland, Florida 32751, United States
  • Kannarr Eye Care
    Pittsburg, Kansas 66762, United States
  • Procare Vision Centers
    Granville, Ohio 43023, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Mar 12, 2024

Documents are hosted by the registry — open the source record to download them.

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

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06333613
Lead sponsor
Johnson & Johnson Vision Care, Inc.
Responsible party
Sponsor
First posted
Mar 27, 2024
Start date
Mar 26, 2024
Primary completion
May 22, 2024
Completion
May 22, 2024
Results posted
Jun 3, 2025
Last update
Jun 3, 2025

Study contacts

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

Oversight

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

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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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