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

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

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

Study Overview

• Status: Completed
• Conditions: Refractive Ametropia
• Intervention / Treatment: Device: etafilcon A control lens (1DM); Device: etafilcon A with print and PVP for light eyes (EALE); Device: etafilcon A with print and PVP for dark eyes (EADE)

• Study Type: Interventional
• Enrollment (Actual): 275
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Mission Viejo, California, United States, 92691
      • Advanced Optometry
    • Mission Viejo, California, United States, 92691
      • James R Dugue, Optometrist
    • Pismo Beach, California, United States, 93448
      • Advance Eye Care
  • Florida
    • Sarasota, Florida, United States, 34242
      • Golden Vision
    • Winter Park, Florida, United States, 32789
      • Eye Associates of Winter Park
  • Illinois
    • Bloomington, Illinois, United States, 61701
      • Eye Care Associates
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Kannarr Eye Care
  • Michigan
    • East Lansing, Michigan, United States, 48826
      • Vision Care
  • New York
    • Jamestown, New York, United States, 14702
      • Spectrum Eye Care
    • Vestal, New York, United States, 13850
      • Sacco Eye Group
  • Oregon
    • Grants Pass, Oregon, United States, 97526
      • The Eye Care Group
  • Rhode Island
    • Warwick, Rhode Island, United States, 02887
      • Dr. David W Ferris and Associates
  • Texas
    • Katy, Texas, United States, 77450
      • Wishnow Sugar Group
  • Wisconsin
    • Middleton, Wisconsin, United States, 53562
      • Isthmus Eye Care
  • Wyoming
    • Laramie, Wyoming, United States, 82070
      • Snowy Range Cision Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 34 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: EALE/1DM; etafilcon A with PVP for light eyes worn during the first period of 7-9 days then etafilcon A control lens worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.	Device: etafilcon A control lens (1DM); A marketed daily disposable contact lens; Other Names: 1-DAY ACUVUE MOIST Brand Contact Lenses; Device: etafilcon A with print and PVP for light eyes (EALE); A daily disposable contact lens
Other: 1DM/EALE; etafilcon A control lens worn during the first period of 7-9 days then etafilcon A with PVP for light eyes worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.	Device: etafilcon A control lens (1DM); A marketed daily disposable contact lens; Other Names: 1-DAY ACUVUE MOIST Brand Contact Lenses; Device: etafilcon A with print and PVP for light eyes (EALE); A daily disposable contact lens
Other: EADE/1DM; etafilcon A with PVP for dark eyes worn during the first period of 7-9 days then etafilcon A control lens worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.	Device: etafilcon A control lens (1DM); A marketed daily disposable contact lens; Other Names: 1-DAY ACUVUE MOIST Brand Contact Lenses; Device: etafilcon A with print and PVP for dark eyes (EADE); A daily disposable contact lens
Other: 1DM/EADE; etafilcon A control lens worn during the first period of 7-9 days then etafilcon A with PVP for dark eyes worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.	Device: etafilcon A control lens (1DM); A marketed daily disposable contact lens; Other Names: 1-DAY ACUVUE MOIST Brand Contact Lenses; Device: etafilcon A with print and PVP for dark eyes (EADE); A daily disposable contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monocular Visual Acuity	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.	Dispensing
Lens Fit Acceptance	The overall lens fit was evaluated by the Investigators for each eye whether it was acceptable (yes/no).	Dispensing
Corneal Staining of Grade 3 or 4	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.	After 7-9 days of lens wear

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: November 30, 2011
• First Submitted That Met QC Criteria: November 30, 2011
• First Posted (Estimate): December 2, 2011

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CR-005094