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

Last updated: March 27, 2025
Sponsor: Johnson & Johnson Vision Care, Inc.
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

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

Clinical Study ID

NCT06333613
CR-6565
  • Ages 13-39
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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 fullyexecuted 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 ofInformed Consent (Parental Permission Form and Authorization to Use and DiscloseMedical Information). (For subjects aged 13 to 17)

  4. Appear able and willing to adhere to the instructions set forth in this clinicalprotocol.

  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 toinsert contact lenses.

  7. Have a pair of prescription glasses on hand that corrects distance vision, ifdetermined to be required by the investigator.

  8. The magnitude of the cylindrical component of the subject's vertex-correcteddistance refraction must be ≤ 0.75 DC in each eye.

  9. Subject must have a vertex corrected distance sphero-cylindrical refraction in therange such that appropriate spherical lens powers are available for correction inboth 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 eacheye.

Exclusion

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 usemedications that the investigator believes might contraindicate or interfere withcontact lens wear, or otherwise compromise the study endpoints. See section 9.1 foradditional details regarding systemic medications.

  4. Have previously participated in a contact lens, contact lens package, or lens carerelated clinical trial.

  5. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate familymember of an employee (including partner, child, parent, grandparent, grandchild, orsibling of the employee or their spouse) of the clinical site.

  6. Have clinically significant (grade 3 or higher on the FDA grading scale) slit lampfindings or other corneal, eyelid, or ocular disease or abnormalities that theinvestigator believes might contraindicate contact lens wear or may otherwisecompromise study endpoints (including significant blepharitis, entropion, ectropion,ptosis, chalazia, recurrent styes, pterygium, significant dry eye disease, historyof 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 orsystemic conditions.

  9. Have had or have planned (within the study period) any ocular or intraocular surgeryor procedures (e.g., PRK, LASIK, IPL, blepharoplasty, etc.)

Study Design

Total Participants: 36
Treatment Group(s): 1
Primary Treatment: ACUVUE OASYS® 1-DAY with HydraLuxe™ TECHNOLOGY (AO1D)
Phase:
Study Start date:
March 26, 2024
Estimated Completion Date:
May 22, 2024

Connect with a study center

  • Scripps Poway Eyecare & Optometry

    San Diego, California 92131
    United States

    Site Not Available

  • Omega Vision Center

    Longwood, Florida 32779
    United States

    Site Not Available

  • Maitland Vision Center - North Orlando Ave

    Maitland, Florida 32751
    United States

    Site Not Available

  • Kannarr Eye Care

    Pittsburg, Kansas 66762
    United States

    Site Not Available

  • Procare Vision Centers

    Granville, Ohio 43023
    United States

    Site Not Available

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