Clinical trial NCT06333613: Evaluation of Acuvue Oasys 1-Day Contact Lenses in New Wearers
Official title: Evaluation of Acuvue Oasys 1-Day Contact Lenses in New Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2024-03-27
Enrollment: 36
Sex: ALL
Minimum age (years): 13
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.)

Primary outcomes:
measure: Incidence (Percentage) of Eyes With Grade 3 or 4 Slit Lamp Findings Related to the Study Lenses
timeFrame: Up to 2-Week Follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Scripps Poway Eyecare & Optometry
state: California
city: Longwood
country: United States
facility: Omega Vision Center
state: Florida
city: Maitland
country: United States
facility: Maitland Vision Center - North Orlando Ave
state: Florida
city: Pittsburg
country: United States
facility: Kannarr Eye Care
state: Kansas
city: Granville
country: United States
facility: Procare Vision Centers
state: Ohio
Study officials:
affiliation: Johnson & Johnson Vision Care, Inc.
name: Johnson & Johnson Vision Care, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: