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

Not Applicable

Completed

• Conditions: Visual Acuity
• Interventions: Device: ACUVUE OASYS® 1-DAY with HydraLuxe™ TECHNOLOGY (AO1D)

• Registration Number: NCT06333613
• Lead Sponsor: Johnson & Johnson Vision Care, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-21
• Study First Submitted QC: 2024-03-21
• Study Start: 2024-03-26
• Study First Posted: 2024-03-27
• Primary Completion: 2024-05-22
• Study Completion: 2024-05-22
• Status Verified: 2025-05
• Results First Submitted: 2025-05-15
• Results First Submitted QC: 2025-05-15
• Last Update Submitted: 2025-05-15
• Results First Posted: 2025-06-03
• Last Update Posted: 2025-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test Lens	ACUVUE OASYS® 1-DAY with HydraLuxe™ TECHNOLOGY (AO1D)	Eligible subjects will be fitted bilaterally with the TEST lens for approximately 2 weeks of wear (two 1-week wear periods).

Primary Outcome Measures

Name	Time	Method
Incidence (Percentage) of Eyes With Grade 3 or 4 Slit Lamp Findings Related to the Study Lenses	Up to 2-Week Follow-up	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.

Trial Locations

Locations (5)

Omega Vision Center; 🇺🇸 Longwood, Florida, United States

Procare Vision Centers; 🇺🇸 Granville, Ohio, United States

Scripps Poway Eyecare & Optometry; 🇺🇸 San Diego, California, United States

Kannarr Eye Care; 🇺🇸 Pittsburg, Kansas, United States

Maitland Vision Center - North Orlando Ave; 🇺🇸 Maitland, Florida, United States