Skip to main content
OpenTrials
Completed

NCT Number: NCT04529109

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–29 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Vital Eyecare Center, Mong Kok, Kowloon, Hong Kong

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-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.

Exclusion criteria

  • 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.

Treatment and study plan

etafilcon A investigational cosmetic lens 1

Device

TEST

etafilcon A investigational cosmetic lens 2

Device

CONTROL

Primary outcomes

  1. Proportion of Eyes With Distance Monocular Visual Acuity (logMAR) Lower Than 0.176 logMAR

    Time frame: 5- Minutes Post-Lens Fitting

    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.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 27, 2020
Registry last updated
Nov 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.