Clinical Evaluation of Two Cosmetic Contact Lenses

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

Study Overview

• Status: Completed
• Conditions: Visual Acuity
• Intervention / Treatment: Device: etafilcon A with PVP with cosmetic pattern contact lens; Device: 1-DAY ACUVUE® DEFINE® with LACREON®, FRESH Honey

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Maitland, Florida, United States, 32751
      • Maitland Vision Center - North Orlando Ave

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Lens/Control Lens; 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.	Device: etafilcon A with PVP with cosmetic pattern contact lens; Test Lens; Device: 1-DAY ACUVUE® DEFINE® with LACREON®, FRESH Honey; Control Lens
Experimental: Control Lens/Test Lens; 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.	Device: etafilcon A with PVP with cosmetic pattern contact lens; Test Lens; Device: 1-DAY ACUVUE® DEFINE® with LACREON®, FRESH Honey; Control Lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance Monocular logMAR Visual Acuity	Distance Monocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. Visual acuity is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.	Fitting Evaluation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mechanical Lens Fit	Lens fitting will be assessed in each eye using a slit-lamp post lens fitting. Lens fitting characteristics to be reported are: Lens Centration Grade; Decentered Direction; Limbal Exposure Grade; Edge Lift (Present or Absent); Primary Gaze Movement Grade; Upgaze Movement Grade; Lens Tightness Grade (Push-up Test); Acceptable Fitting (yes/no)	After approximately 90-minute lens wear period
Cosmetic Lens Fit	Cosmetic lens fit assessment will be performed in each eye at post lens fitting by the investigator without the use of a slit-lamp at a distance of approximately 3 feet from the subject in: Primary Gaze; Extreme Gaze (left and right); Extreme Up-gaze	After approximately 90-minute lens wear period
Percentage of Eyes Reporting Moderate or Severe Ocular Symptoms (Subject-Reported)	Frequency (counts and percentages of eyes) of moderate or severe ocular symptoms with the study lens will be assessed at fitting. Severity of the symptoms can be: 0 = Not Applicable or Not Recorded; = Mild and results in little or no interference with lens wear; = Moderate AND / OR occasionally interferes with lens wear; = Severe AND / OR frequently interferes with lens wear	After approximately 90-minute lens wear period
Ocular Physiology (Slit Lamp Findings)	Slit lamp findings will be assessed for each subject eye before and after each lens fitting using the FDA Grading scale (Grade 0=None, Grade 1=Trace, Grade 2=Mild, Grade 3=Moderate, Grade 4=Severe). Slit lamp finding assessments include the following metrics: Corneal Infiltrates (Yes/No); Corneal Edema; Corneal Neovascularization; Corneal Neovascularization Location; Corneal Staining; Corneal Staining Location; Conjunctival Injection; Tarsal Abnormalities; Other	After approximately 90-minute lens wear period

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.
• Investigators: Study Director: Johnson & Johnson Vision Care, Inc. Clinical Trial, Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2025
• Primary Completion (Actual): May 5, 2025
• Study Completion (Actual): May 5, 2025

Study Registration Dates

• First Submitted: February 14, 2025
• First Submitted That Met QC Criteria: March 3, 2025
• First Posted (Actual): March 7, 2025

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: CR-6571

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes