Evaluation of Visual Performance of Two Types of Cosmetic Contact Lenses

NCT04534764 | Completed Results FDA Device

• 1 other identifier: CR-6060
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single visit, brand-masked, non-dispensing, 2×2 bilateral crossover study. Each subject will be bilaterally fitted with one of the two test articles in each of the study periods in a random order with a 5-minute washout period in between study lenses.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (1)

• Distance Monocular Visual Acuity (logMAR)

  Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters) under high luminance low contrast and low luminance high contrast lighting conditions 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.

  5 min post lens insertion

Study Arms (2)

TEST/CONTROL

EXPERIMENTAL

Eligible subjects that are habitual soft contact lens wearers will be randomized into lens wear sequence (Test/Control)

Device: etafilcon A with cosmetic pattern; Device: 1-Day Acuvue DEFINE Vivid Style

CONTROL/TEST

EXPERIMENTAL

Eligible subjects that are habitual soft contact lens wearers will be randomized into lens wear sequence (Control/Test)

Device: etafilcon A with cosmetic pattern; Device: 1-Day Acuvue DEFINE Vivid Style

Interventions

etafilcon A with cosmetic pattern DEVICE

TEST

CONTROL/TEST; TEST/CONTROL

1-Day Acuvue DEFINE Vivid Style DEVICE

CONTROL

CONTROL/TEST; TEST/CONTROL

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• 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
• Appear able and willing to adhere to the instructions set forth in this clinical Protocol.
• Subjects between 18 and 39 (inclusive) years of age at the time of screening
• 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.
• 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:

• Potential subjects who meet any of the following criteria will be excluded from participating in the study:
• 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.)
• 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 (1)

Maitland Vision Center

Maitland, Florida, 32751, United States

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: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: September 1, 2020
• Study Start: July 31, 2020
• Primary Completion: August 12, 2020
• Study Completion: August 12, 2020
• Last Updated: September 1, 2021
• Results First Posted: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)