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

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

Study Overview

• Status: Recruiting
• Conditions: Visual Acuity
• Intervention / Treatment: Device: ACUVUE OASYS® 1-DAY with HydraLuxe™ TECHNOLOGY (AO1D)

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 1-800-843-2020; Email: osova@ITS.JNJ.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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:

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); Test Lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of eyes with slit-lamp findings (Grade 3 or 4) related to study lens wear	The percentage of eyes with Grade 3 or higher SLFs related to study lens wear will be evaluated and classified using the FDA Grading scale rating from 0 to 4, where 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).	up to 2-weeks of wear

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.
• Investigators: Study Director: Johnson & Johnson Vision Care, Inc. Clinical Trial, Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2024
• Primary Completion (Estimated): May 20, 2024
• Study Completion (Estimated): May 20, 2024

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 27, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CR-6565

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes