Evaluation of the Cosmetic Performance of AIR OPTIX® COLORS

Study Overview
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Brief Summary
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The purpose of this study was to evaluate the cosmetic performance of AIR OPTIX® COLORS contact lenses compared to FRESHLOOK® COLORBLENDS contact lenses in habitual FRESHLOOK® COLORBLENDS contact lens wearers.

Detailed Description
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In this non-dispensing trial, each participant wore 4 pairs of color contact lenses (gray, blue, green, hazel) sequentially for less than 10 minutes each in a contralateral fashion (test lens in one eye, control lens in the other eye). Randomization took place for each of the 4 pairs of lenses as to which eye (left or right) wore the test and which wore the control. Participants were selected based on eye color (dark vs light/medium). The primary analysis population (AP1) was pre-specified as participants of any eye color who habitually wore FRESHLOOK® COLORBLENDS lenses in one of the four colors tested in this trial. Pair 1 lenses were dispensed per the participant's habitual lens color.

Official Title
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Cosmetic Validation (US): AIR OPTIX® COLORS Among Habitual Wearers of FRESHLOOK®

Conditions
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Cosmetic Appearance

Intervention / Treatment
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* Device: Lotrafilcon B contact lens with color
* Device: Phemfilcon A contact lens with color


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign written Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document. Have spectacles that provide acceptable near vision to wear over study lenses as needed to evaluate cosmetics of the lenses. Habitually wear FRESHLOOK® COLORBLENDS lenses at least two days per week. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Eye injury or surgery within twelve weeks of enrollment in this trial. Pre-existing ocular irritation that would preclude contact lens fitting. Currently enrolled in any clinical trial. Evidence of systematic 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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: AIR OPTIX® COLORS<br>Lotrafilcon B contact lens with color randomly assigned to one eye, with phemfilcon A contact lens with color in the fellow eye for contralateral wear | Device: Lotrafilcon B contact lens with color<br>* Plano (-0.00 diopter) silicone hydrogel contact lens in 1 of 4 colors: gray, blue, green, pure hazel<br>* Other names: AIR OPTIX® COLORS;|
| Active Comparator: FRESHLOOK® COLORBLENDS<br>Phemfilcon A contact lens with color randomly assigned to one eye, with lotrafilcon B contact lens with color in the fellow eye for contralateral wear | Device: Phemfilcon A contact lens with color<br>* Plano (-0.00 diopter) hydrogel contact lens in 1 of 4 colors: ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel<br>* Other names: FRESHLOOK® COLORBLENDS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Preference | The participant compared Pair 1 study lenses on eye and indicated overall preference using a 4-point Likert scale (prefer lens in the left eye, prefer lens in the right eye, no preference, or both eyes are equal). Overall preference is reported as the percentage of participants who preferred the study lens. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1). | Day 1, 2-10 minutes after lens insertion | 
| Initial Comfort Preference | The participant compared the initial comfort (way it feels) of Pair 1 study lenses and indicated preference using a 4-point Likert scale (prefer lens in the left eye, prefer lens in the right eye, no preference, or both eyes are equal). Initial comfort preference is reported as the percentage of participants who preferred the study lens. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1). | Day 1, 2 minutes after lens insertion | 
| Appearance Preference | The participant compared the appearance (way it looks) of Pair 1 study lenses on eye and indicated preference using a 4-point Likert scale (prefer lens in the left eye, prefer lens in the right eye, no preference, or both eyes are equal). Appearance preference is reported as the percentage of participants who preferred the study lens. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1). | Day 1, 2-10 minutes after lens insertion | 
| Subjective Rating of Initial Comfort | The participant compared the initial comfort (way it feels) of Pair 1 study lenses and rated initial comfort using a 10-point scale (1=poor, 10=excellent). Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1). | Day 1, 2 minutes after lens insertion | 
| Percent Positive Responses: Cosmetic Appearance (Strongly Agree, Agree) | The participant compared the cosmetic appearance of Pair 1 study lenses on eye and answered 9 appearance-related questions using a 4-point Likert scale (strongly agree, agree, disagree, strongly disagree). The combined percentage of the top two responses (strongly agree, agree) is reported for each question. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1). | Day 1, 2-10 minutes after lens insertion | 
| Percent Positive Purchase Intent (Definitely Would Buy, Probably Would Buy) | The participant compared Pair 1 study lenses and indicated purchase intent by answering the following question, Assuming these lenses were at a price you would expect to pay, how likely would you be to purchase these lenses? using a 5-point Likert scale (definitely would buy, probably would buy, might or might not buy, probably would not buy, definitely would not buy). The combined percentage of the top two responses (definitely would buy, probably would buy) is reported. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1). | Day 1, 2-10 minutes after lens insertion |