Clinical Evaluation of Daily Disposable Etafilcon A Cosmetic Contact Lenses

This will be a randomized, double-masked, bilateral, cross-over, 2 treatment by 2 period dispensing study. There will be 4 visits. There will be a 2 to 5 day washout period between treatments.

Study Overview

• Status: Completed
• Conditions: Visual Acuity
• Intervention / Treatment: Device: etafilcon A investigational cosmetic lens 1; Device: etafilcon A investigational cosmetic lens 2

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Kowloon
    • Mongkok, Kowloon, Hong Kong
      • Vital Eyecare Center
    • Yau Ma Tei, Kowloon, Hong Kong
      • Sight Enhancement Center
• United States
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Stam & Associates Eye Care
  • Texas
    • Tyler, Texas, United States, 75703
      • Frazier Vision, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 29 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form
2. Females between 18 and 29 (inclusive) years of age at the time of screening
3. Appear able and willing to adhere to the instructions set forth in this clinical protocol (i.e. willing to wear only the study lenses and not use habitual lenses during the dispensing periods)
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 month by self-report
5. Be a current wearer of cosmetic/circle lenses in the last 6 months, by self-report.
6. The subject must be willing to be photographed and/or video-taped
7. 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
8. The subject's refractive cylinder must be less than or equal to 0.75 D (inclusive) in each eye
9. Have spherical best corrected visual acuity of 20/25 or better in each eye.

Exclusion Criteria:

1. Currently pregnant or lactating
2. 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 investigators discretion)
3. Use of systemic medications (eg, chronic steroid use) that are known to interfere with contact lens wear (at the investigators discretion)
4. Any previous or planned (during the study) ocular surgery (eg, radial keratotomy, PRK, LASIK, etc.).
5. 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 investigators discretion).
6. Participation in any contact lens or lens care product clinical trial within seven (7) days prior to study enrollment
7. Employee or family members of clinical site (eg, Investigator, Coordinator, Technician)
8. 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 investigators discretion)
9. 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: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test/Control; Eligible subjects that are habitual soft contact lens wearers and current wearers of circle/cosmetic contact lenses will be randomized into lens wear sequence (Test/Control).	Device: etafilcon A investigational cosmetic lens 1; TEST; Device: etafilcon A investigational cosmetic lens 2; CONTROL
Experimental: Control/Test; Eligible subjects that are habitual soft contact lens wearers and current wearers of circle/cosmetic contact lenses will be randomized into lens wear sequence (Control/Test).	Device: etafilcon A investigational cosmetic lens 1; TEST; Device: etafilcon A investigational cosmetic lens 2; CONTROL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Eyes With Distance Monocular Visual Acuity (logMAR) Lower Than 0.176 logMAR	Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters) under high luminance high contrast lighting condition 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. However, the data was dichotomized as Y=1 if logMAR visual acuity was less than 0.176 logMAR; and Y=0 otherwise. A value of 0.176 logMAR ≅20/30 Snellen Visual Acuity. The proportion of eyes with visual acuity lower than 0.176 logMAR was reported.	5- Minutes Post-Lens Fitting

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2020
• Primary Completion (Actual): September 15, 2020
• Study Completion (Actual): September 15, 2020

Study Registration Dates

• First Submitted: August 25, 2020
• First Submitted That Met QC Criteria: August 25, 2020
• First Posted (Actual): August 27, 2020

Study Record Updates

• Last Update Posted (Actual): November 24, 2021
• Last Update Submitted That Met QC Criteria: October 29, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CR-6395

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
• product manufactured in and exported from the U.S.: Yes