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

Visual Acuity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06333613
• Other study ID #: CR-6565
• Status: Completed
• Phase: N/A
• Start date: March 26, 2024
• Est. completion date: May 22, 2024

Study information

• Verified date: June 2024
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 22, 2024
• Est. primary completion date: May 22, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 39 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Visual Acuity

Intervention

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

Locations

Country	Name	City	State
United States	Procare Vision Centers	Granville	Ohio
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	Scripps Poway Eyecare & Optometry	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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