Asian Clinical Evaluation of an Investigational Contact Lens for Cosmetic Effect

Study Overview
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Brief Summary
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The purpose of this study is to compare the cosmetic appearance of two different contact lenses on Asian eyes.

Detailed Description
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Participants will be asked to evaluate the cosmetic appearance of two different contact lenses worn contralaterally for 20 minutes. No vision or comfort variables will be assessed in this cosmetic appearance and lens fit non-dispensing study.

Conditions
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Cosmetic Appearance

Intervention / Treatment
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* Device: nelfilcon A contact lens with print
* Device: etafilcon A contact lens with print


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female between 18 and 30 years of age (inclusive). If under 21 years of age, subject must sign informed assent and have written consent of parent or guardian to participate. Sign written Informed Consent. Chinese, Japanese, or Korean descent. Brown eye color. Spherical equivalent refractive error of -0.50 diopter (D) and between (-1.50 to -2.50D), (-3.50 to -4.50D) and (-5.50 to -6.50D). Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Eye injury or surgery within twelve weeks prior to enrollment. Pre-existing ocular irritation that would preclude contact lens fitting. Currently enrolled in any clinical ophthalmic trial. Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of accessory solutions as determined by the investigator. Any use of medications for which contact lens wear could be contraindicated as determined by the investigator. Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 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

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nelfilcon A<br>Nelfilcon A printed contact lens randomly assigned to one eye, with etafilcon A printed contact lens assigned to the fellow eye for contralateral wear. Lenses will be worn for 20 minutes. | Device: nelfilcon A contact lens with print<br>* Investigational spherical contact lens<br>|
| Active Comparator: etafilcon A<br>Etafilcon A printed contact lens randomly assigned to one eye, with nelfilcon A printed contact lens assigned to the fellow eye for contralateral wear. | Device: etafilcon A contact lens with print<br>* Commercially marketed (Singapore) spherical contact lens<br>* Other names: 1-DAY ACUVUE DEFINE Vivid Style;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cosmetic Appearance Preference | Participant will be asked on a questionnaire, Which lens do you prefer for looking more natural? Subject will record on the questionnaire, Left lens, Right lens, or No preference. | After 20 minutes of wear | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Centration | Investigator will assess lens centration using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens centration will be graded on a 5-point scale, with 0 being centered and 4 being severe decentration with corneal exposure. | After insertion and before 20 minutes of wear |