Dispensing Evaluation of Subjective Comfort, Vision, and Handling of a New Lens Compared to a Marketed Lens

Study Overview
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Brief Summary
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To evaluate and compare the performance of a new contact lens to a marketed contact lens.

Official Title
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Dispensing Evaluation of Lens Comfort and Subjective Vision of an Etafilcon A With Print and PVP Lens for Dark Eyes

Conditions
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Refractive Ametropia

Intervention / Treatment
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* Device: etafilcon A with print and PVP for dark eyes (EAPVPDE)
* Device: etafilcon A control lens (EADE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject must be a healthy adult at least 18 years of age and no more than 34 years of age. The subjects must be female, dark eye Caucasian, Non-Hispanic habitual soft contact lens wearer (both eyes). The subject rated the Concept Statement positively (i.e., a rating of 4 or 5). If not the subject is not eligible to participate. The subject must have no known ocular or systemic allergies that might interfere with contact lens wear. The subject must have no known systemic disease, or need for medication, which might interfere with contact lens wear. The subject's optimal vertexed spherical equivalent distance correction must be between-1.00 and -4.00D. Any cylinder power must be:<=0.75D. The subject must have visual acuity best correctable to 20/25 or better for each eye. The subject must have normal eyes (no ocular medications or ocular infection of any type). The subject must read and sign the Statement of Informed Consent. The subject 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 (color blindness) - 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 is 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: EAPVPDE/EADE<br>etafilcon A with embedded print and PVP lens for dark eyes worn daily during the first period of 7-9 days, then etafilcon A control lens worn daily during the second period of 7-9 days, with 1-3 days of wash-out time between the 2 periods. | Device: etafilcon A with print and PVP for dark eyes (EAPVPDE)<br>* A daily disposable contact lens<br>Device: etafilcon A control lens (EADE)<br>* A marketed daily disposable contact lens<br>|
| Other: EADE/EAPVPDE<br>etafilcon A control lens worn daily during the first period of 7-9 days, then etafilcon A with embedded print and PVP for dark eyes lens worn daily during the second period of 7-9 days, with 1-3 days of wash-out time between the 2 periods. | Device: etafilcon A with print and PVP for dark eyes (EAPVPDE)<br>* A daily disposable contact lens<br>Device: etafilcon A control lens (EADE)<br>* A marketed daily disposable contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Reported Overall Quality of Lens Vision Using the Contact Lens User Evaluation (CLUE) Questionnaire | The overall quality of lens vision was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range from 0-120. | After 7 to 9 days of lens wear | 
| Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE) Questionnaire | The overall lens comfort was assessed using the CLUE questionnaire after 7-9 days of follow-up.The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. | After 7 to 9 days of lens wear | 
| Subject Reported Overall Lens Handling Using the Contact Lens User Evaluation (CLUE) Questionnaire | The overall lens handling was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. | After 7 to 9 days of lens wear |