Skip to main content
OpenTrials
Completed

NCT Number: NCT01484028

Evaluation of the Performance of Two Contact Lenses Compared to a Marketed Lens

This study will serve to evaluate and compare the performance of two new lenses to a marketed lens.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–34 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Advanced Optometry, Mission Viejo, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Healthy, female adult, at least 18 years of age, and no more than 34 years of age
  • The subjects must be female, light eye Caucasian, Non-Hispanic, habitual soft contact lens wearer (both eyes) with light or dark eyes
  • Must have rated the Concept Statement positively (i.e., a rating of 4 or 5).
  • Optimal vertexed spherical equivalent distance correction must be between -1.00 and -4.00 diopters (D)
  • Any cylinder power must be: <=0.75D
  • Visual acuity must be best correctable to 20/25 or better for each eye
  • Must have normal eyes (no ocular medications or ocular infection of any type)
  • Must read and sign the Statement of Informed Consent
  • Must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion criteria

  • Ocular or systemic allergies or disease which might interfere with contact lens wear
  • Systemic disease, autoimmune disease, or use of medication which might interfere with contact lens wear
  • Clinically significant (grade 3 or worse) corneal edema, corneal neovascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear
  • Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear
  • Any ocular infection
  • Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear
  • Any color deficiencies (colorblindness) - to the best of the subject's knowledge
  • Pregnancy or lactation
  • Diabetes
  • Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV)
  • Habitual contact lens type is toric, multifocal, or is worn as extended wear.
  • Subject presents with one dark iris color and one light iris color.
  • Subject has heterochromia iridis (a difference in color between parts of one iris).
  • The subject must not be an employee or family member of the clinical study site.

Treatment and study plan

etafilcon A control lens (1DM)

Device

A marketed daily disposable contact lens

Other names: 1-DAY ACUVUE MOIST Brand Contact Lenses

etafilcon A with print and PVP for light eyes (EALE)

Device

A daily disposable contact lens

etafilcon A with print and PVP for dark eyes (EADE)

Device

A daily disposable contact lens

Primary outcomes

  1. Monocular Visual Acuity

    Time frame: Dispensing

    Monocular distance Snellen visual acuity (VA) scores were coverted to the algorithm of the minimal angle of resolution (LogMAR) scale based on the following formula: LogMAR = Log10 (VA/20) - a*VAR, where Log10 = base 10 logarithm, VA = the Snellen denominator score, a = LogMAR stepsize coefficient and VAR = letter gained or missing in addition to the Snellen denominator score.

  2. Lens Fit Acceptance

    Time frame: Dispensing

    The overall lens fit was evaluated by the Investigators for each eye whether it was acceptable (yes/no).

  3. Corneal Staining of Grade 3 or 4

    Time frame: After 7-9 days of lens wear

    Corneal staining was graded using a 5-point scale; 0=None(no staining), 1=Trace, 2=Mild, 3=Moderate, and 4=Severe. Only those eyes with corneal staining grade >= 3 were reported.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Official study title

Clinical Validation of Etafilcon A With Print and PVP Contact Lenses for Dark Eyes and Light Eyes

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 2, 2011
Registry last updated
Jun 19, 2018

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.