Clinical Evaluation of Daily Disposable Etafilcon A Cosmetic Contact Lenses

NCT04529109 | Completed Results FDA Device

• 1 other identifier: CR-6395
• Study Type: interventional
• Target: 58
• Locations: 2 countries
• Sites: 4

Brief Summary

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.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Test/Control

EXPERIMENTAL

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; Device: etafilcon A investigational cosmetic lens 2

Control/Test

EXPERIMENTAL

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; Device: etafilcon A investigational cosmetic lens 2

Interventions

etafilcon A investigational cosmetic lens 1 DEVICE

TEST

Control/Test; Test/Control

etafilcon A investigational cosmetic lens 2 DEVICE

CONTROL

Control/Test; Test/Control

Eligibility Criteria

• Age: 18 Years - 29 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Potential subjects must satisfy all of the following criteria to be enrolled in the study:
• The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form
• Females between 18 and 29 (inclusive) years of age at the time of screening
• 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)
• 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
• Be a current wearer of cosmetic/circle lenses in the last 6 months, by self-report.
• The subject must be willing to be photographed and/or video-taped
• 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
• The subject's refractive cylinder must be less than or equal to 0.75 D (inclusive) in each eye
• Have spherical best corrected visual acuity of 20/25 or better in each eye.

You may not qualify if:

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

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (4)

Stam & Associates Eye Care

Jacksonville, Florida, 32256, United States

Location

Frazier Vision, Inc

Tyler, Texas, 75703, United States

Location

Vital Eyecare Center

Mong Kok, Kowloon, Hong Kong

Location

Sight Enhancement Center

Yau Ma Tei, Kowloon, Hong Kong

Location

Results Point of Contact

• Title: Meredith Bishop, OD, MS, FAAO-Sr. Principal Research Optometrist
• Organization: Johnson & Johnson Vision Care

mbishop4@its.jnj.com

904-443-1783

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: August 27, 2020
• Study Start: August 13, 2020
• Primary Completion: September 15, 2020
• Study Completion: September 15, 2020
• Last Updated: November 24, 2021
• Results First Posted: November 24, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share

Locations

US (2); HK (2)