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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AIR OPTIX® COLORS | Experimental | 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 |
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| FRESHLOOK® COLORBLENDS | Active Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lotrafilcon B contact lens with color | Device | Plano (-0.00 diopter) silicone hydrogel contact lens in 1 of 4 colors: gray, blue, green, pure hazel |
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| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon Holden Thomas, O.D. | Alcon Research | Study Director |
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Of the 198 enrolled participants, 1 was exited as a screen failure prior to study product exposure. This reporting group includes all enrolled and exposed participants (197).
Participants were recruited from 18 US study centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | AIR OPTIX® COLORS/FRESHLOOK® COLORBLENDS | AIR OPTIX® COLORS and FRESHLOOK® COLORBLENDS, contralateral wear |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The analysis population includes all enrolled and exposed participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | AIR OPTIX® COLORS/FRESHLOOK® COLORBLENDS | AIR OPTIX® COLORS and FRESHLOOK® COLORBLENDS, contralateral wear |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | The analysis population includes all enrolled and exposed participants in AP1, minus any discontinuations, missing responses, or protocol violations as determined by masked review. | Posted | Number | Percentage of participants | Day 1, 2-10 minutes after lens insertion |
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Adverse events (AEs) were collected for the duration of the study (5 months). An AE was defined as any untoward device experience with investigational or marketed product, whether it was considered to be device related or not.
The analysis population includes all enrolled and exposed participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AIR OPTIX® COLORS | Lotrafilcon B silicone hydrogel contact lens in 4 colors (gray, blue, green, pure hazel) worn in one eye, up to 10 minutes each |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sharon Holden Thomas, Sr. Principal Clinical Scientist | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| Phemfilcon A contact lens with color | Device | Plano (-0.00 diopter) hydrogel contact lens in 1 of 4 colors: ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel |
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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 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| OG001 | FRESHLOOK® COLORBLENDS | Phemfilcon A hydrogel contact lens in 1 of 4 colors (ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel) worn in one eye for up to 10 minutes |
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| Primary | 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). | The analysis population includes all enrolled and exposed participants in AP1, minus any discontinuations, missing responses, or protocol violations as determined by masked review. | Posted | Number | Percentage of participants | Day 1, 2 minutes after lens insertion |
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| Primary | 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). | The analysis population includes all enrolled and exposed participants in AP1, minus any discontinuations, missing responses, or protocol violations as determined by masked review. | Posted | Number | Percentage of participants | Day 1, 2-10 minutes after lens insertion |
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| Primary | 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). | The analysis population includes all enrolled and exposed participants in AP1, minus any discontinuations, missing responses, or protocol violations as determined by masked review. | Posted | Mean | Standard Deviation | Units on a scale | Day 1, 2 minutes after lens insertion |
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| Primary | 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). | The analysis population includes all enrolled and exposed participants in AP1, minus any discontinuations, missing responses, or protocol violations as determined by masked review. | Posted | Number | Percentage of participants | Day 1, 2-10 minutes after lens insertion |
|
|
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| Primary | 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). | The analysis population includes all enrolled and exposed participants in AP1, minus any discontinuations, missing responses, or protocol violations as determined by masked review. | Posted | Number | Percentage of participants | Day 1, 2-10 minutes after lens insertion |
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| 0 |
| 197 |
| 0 |
| 197 |
| EG001 | FRESHLOOK® COLORBLENDS | Phemfilcon A hydrogel contact lens in 4 colors (ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel) worn in one eye, up to 10 minutes each | 0 | 197 | 0 | 197 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| The lens makes my eye look bright |
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| The lens makes my eye look beautiful |
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| The lens makes my eye noticeable |
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| The lens enhances my eye color |
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| I like the way my eye looks |
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| The lens makes me look beautiful |
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| The lens transforms the color of my eye |
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