Quantitative Study of New Limbal Ring Prototypes

Study Overview
=================
Brief Summary
-----------------
The study is designed to test five new soft contact lens color pattern variants to determine whether the test lens makes the wearers eyes look bigger, more defined or enhances their overall appearance.

Conditions
-----------------
Cosmetic Effect

Intervention / Treatment
-----------------
* Device: etafilcon test contact lens Variant AP
* Device: etafilcon test contact lens Variant JG
* Device: etafilcon test contact lens Variant CS
* Device: etafilcon test contact lens Variant VC
* Device: etafilcon test contact lens Variant LA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject must be at least 18 years of age and no more than 39 years of age (inclusive) Subjects must be Asian female Subjects must be able to read Chinese Subjects' monthly household income must be above HKD$ 10,000 Subjects must be habitual soft contact lens wearer or habitual limbal lens wearer or have a history of previous habitual lens wear. Subjects' current/previous habitual lens must be in the disposable soft lens modality (ranging from daily to monthly) Subjects must have dark colored iris (black, brown, or brown hazel) Subjects must be concept acceptors. Concept acceptors are subjects that are willing to try new circle contact lenses. Subjects must be classified as either 'Classic' or 'Vogue' on a Pattern Evaluation Screening Questionnaire. Subjects must have acceptable near vision (without vision correction) and be able to see the test article lenses in the mirror 30 cm or closer. Subjects must have best corrected visual acuity of 20/40 (Snellen or equivalent) or better in each eye. Subjects must possess a functional/usable pair of spectacles and bring them to the visit (only if applicable-to the investigators discretion) Subjects must read, understand, and sign the Statement of Informed Consent Subjects must appear able and willing to adhere to the instructions set forth in this clinical protocol Exclusion Criteria: Subjects, or subjects' family member within the same household, that work for the following entities/companies: Government, advertising, marketing research or consultancy, media or public relations, companies that make, distribute or sell eyewear or contact lenses, eyecare practice (optometrist, ophthalmologist, optician) or the research center conducting the study Habitual wearers of rigid gas permeable lenses within the last 3 months Habitual soft conventional contact lens wearers (conventional lenses defined as replacement modality of greater than 1 month) Any color deficiencies, by self report Currently pregnant or breast-feeding a baby Diabetes Any ocular or systemic allergies or diseases which may interfere with contact lens wear Any systemic disease, autoimmune disease, or use of medication which may interfere with contact lens wear, at the investigator's discretion Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self report Any grade 3 or greater Biomicroscopy findings (this includes, corneal edema, corneal staining, corneal vascularization, conjunctival injection, tarsal abnormalities, bulbar injection) on the FDA classification scale Any active ocular abnormalities/conditions that may interfere with contact lens wear (this includes, but not limited to, chalazia, recurrent styes, pterygium, infection, etc.) Any corneal distortion or moderate or above corneal distortion by self report History of any corneal refractive surgery Habitual contact lens is multifocal, monovision or worn as extended wear

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: etafilcon test contact lens Variant AP<br> | Device: etafilcon test contact lens Variant AP<br>* Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.<br>Device: etafilcon test contact lens Variant JG<br>* Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.<br>Device: etafilcon test contact lens Variant CS<br>* Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.<br>Device: etafilcon test contact lens Variant VC<br>* Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.<br>Device: etafilcon test contact lens Variant LA<br>* Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.<br>|
| Experimental: etafilcon test contact lens Variant JG<br> | Device: etafilcon test contact lens Variant AP<br>* Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.<br>Device: etafilcon test contact lens Variant JG<br>* Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.<br>Device: etafilcon test contact lens Variant CS<br>* Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.<br>Device: etafilcon test contact lens Variant VC<br>* Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.<br>Device: etafilcon test contact lens Variant LA<br>* Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.<br>|
| Experimental: etafilcon test contact lens Variant CS<br> | Device: etafilcon test contact lens Variant AP<br>* Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.<br>Device: etafilcon test contact lens Variant JG<br>* Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.<br>Device: etafilcon test contact lens Variant CS<br>* Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.<br>Device: etafilcon test contact lens Variant VC<br>* Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.<br>Device: etafilcon test contact lens Variant LA<br>* Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.<br>|
| Experimental: etafilcon test contact lens Variant VC<br> | Device: etafilcon test contact lens Variant AP<br>* Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.<br>Device: etafilcon test contact lens Variant JG<br>* Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.<br>Device: etafilcon test contact lens Variant CS<br>* Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.<br>Device: etafilcon test contact lens Variant VC<br>* Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.<br>Device: etafilcon test contact lens Variant LA<br>* Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.<br>|
| Experimental: etafilcon test contact lens Variant LA<br> | Device: etafilcon test contact lens Variant AP<br>* Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.<br>Device: etafilcon test contact lens Variant JG<br>* Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.<br>Device: etafilcon test contact lens Variant CS<br>* Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.<br>Device: etafilcon test contact lens Variant VC<br>* Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.<br>Device: etafilcon test contact lens Variant LA<br>* Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subject in Agreement (Bigger Eyes) | Subjects' responses to the question Make my eye look bigger were categorized into a binary variable. If a subject responded Agrees Somewhat or Agrees Strongly then response=1. If a subject responds Neither Agrees nor Disagrees, Disagrees Somewhat Disagrees Strongly then response=0. The number of subjects with response=1 was reported for each lens. | 15-20 Minutes Post Lens Insertion | 
| Number of Subject in Agreement (Defines Eyes) | Subjects' responses to the question Define my eye were categorized into a binary variable. If a subject responded Agrees Somewhat or Agrees Strongly then response=1. If a subject responds Neither Agrees nor Disagrees, Disagrees Somewhat Disagrees Strongly then response=0. The number of subjects with response=1 was reported for each lens. | 15-20 Minutes Post Lens Insertion | 
| Number of Subject in Agreement (Enhance Eyes) | Subjects' responses to the question Enhance my overall appearance were categorized into a binary variable. If a subject responded Agrees Somewhat or Agrees Strongly then response=1. If a subject responds Neither Agrees nor Disagrees, Disagrees Somewhat Disagrees Strongly then response=0. The number of subjects with response=1 was reported for each lens. | 15-20 Minutes Post Lens Insertion |