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

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

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

Conditions
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Refractive Ametropia

Intervention / Treatment
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* 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)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 34 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: EALE/1DM<br>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)<br>* A marketed daily disposable contact lens<br>* Other names: 1-DAY ACUVUE MOIST Brand Contact Lenses;Device: etafilcon A with print and PVP for light eyes (EALE)<br>* A daily disposable contact lens<br>|
| Other: 1DM/EALE<br>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)<br>* A marketed daily disposable contact lens<br>* Other names: 1-DAY ACUVUE MOIST Brand Contact Lenses;Device: etafilcon A with print and PVP for light eyes (EALE)<br>* A daily disposable contact lens<br>|
| Other: EADE/1DM<br>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)<br>* A marketed daily disposable contact lens<br>* Other names: 1-DAY ACUVUE MOIST Brand Contact Lenses;Device: etafilcon A with print and PVP for dark eyes (EADE)<br>* A daily disposable contact lens<br>|
| Other: 1DM/EADE<br>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)<br>* A marketed daily disposable contact lens<br>* Other names: 1-DAY ACUVUE MOIST Brand Contact Lenses;Device: etafilcon A with print and PVP for dark eyes (EADE)<br>* A daily disposable contact lens<br>|

What is the study measuring?
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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 |