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

NCT ID: NCT06333613

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-26
• Study Completion Date: 2024-05-22

Brief Summary

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

Conditions

Visual Acuity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Test Lens

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

Test Lens

Interventions

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

Test Lens

Intervention Type: DEVICE

Eligibility Criteria

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.)

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Vision Care, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Vision Care, Inc.

Locations

Scripps Poway Eyecare & Optometry

San Diego, California, United States

Omega Vision Center

Longwood, Florida, United States

Maitland Vision Center - North Orlando Ave

Maitland, Florida, United States

Kannarr Eye Care

Pittsburg, Kansas, United States

Procare Vision Centers

Granville, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CR-6565

Identifier Type: -

Identifier Source: org_study_id