Clinical Evaluation of Two Cosmetic Contact Lenses

Johnson & Johnson (J&J)

Status: Completed

Conditions: Visual Acuity

Treatments: Device: etafilcon A with PVP with cosmetic pattern contact lens; Device: 1-DAY ACUVUE® DEFINE® with LACREON®, FRESH Honey

Study type: Interventional

Funder types: Industry

Identifiers

NCT06864858

CR-6571

Details and patient eligibility

About

This is a single visit, single-masked, non-dispensing, randomized, controlled, 2×2 bilateral crossover study to evaluate visual acuity.

Enrollment: 53 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Potential subjects must satisfy all of the following criteria to be enrolled in the study:

1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. Be between 18 and 39 (inclusive) years of age at the time of screening.
4. Be a current soft contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week over the last 30 days by self-report.
5. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 D to -6.00 D (inclusive) in each eye.
6. The subject's refractive cylinder must be less than or equal to 0.75 D (inclusive) in each eye.
7. Have spherical best corrected visual acuity of 20/25 or better in each eye.

Potential subjects who meet any of the following criteria will be excluded from participating in the study:

1. Be currently pregnant or lactating.
2. Have any systemic disease (eg, Sjögren's Syndrome), allergies, infectious disease (eg, hepatitis, tuberculosis), contagious immunosuppressive diseases (eg, HIV), autoimmune disease (eg rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study (at the investigator's discretion).
3. Use of systemic medications (eg, chronic steroid use) that are known to interfere with contact lens wear (at the investigator's discretion).
4. Have any previous, or planned (during the study), ocular surgery (eg, radial keratotomy, PRK, LASIK, etc.).
5. Have any previous history or signs of a contact lens-related corneal inflammatory event (eg, past peripheral ulcer or round peripheral scar), or any other ocular abnormality that would contraindicate contact lens wear (at the investigator's discretion).
6. Have participated in any contact lens or lens care product clinical trial within seven (7) days prior to study enrollment.
7. 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.
8. Have any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion (at the investigator's discretion).
9. Have any clinically significant (Grade 3 or 4 on FDA scale) tarsal abnormalities, bulbar injection, corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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53 participants in 2 patient groups

Test Lens/Control Lens

Experimental group

Description:

Eligible subjects will be randomized into the Test Lens/Control Lens sequence, to wear the Test Lens followed by the Control Lens in a bilateral fashion, with a washout period of 5-minutes between wear periods.

Treatment:

Device: 1-DAY ACUVUE® DEFINE® with LACREON®, FRESH Honey

Device: etafilcon A with PVP with cosmetic pattern contact lens

Control Lens/Test Lens

Experimental group

Description:

Eligible subjects will be randomized into the Control Lens/Test Lens sequence, to wear the Control Lens followed by the Test Lens in a bilateral fashion, with a washout period of 5-minutes between wear periods.

Treatment:

Device: 1-DAY ACUVUE® DEFINE® with LACREON®, FRESH Honey

Device: etafilcon A with PVP with cosmetic pattern contact lens