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The purpose of this study was to evaluate overall satisfaction with AIR OPTIX® COLORS as compared to FRESHLOOK® COLORBLENDS contact lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AIR OPTIX® COLORS | Experimental | Lotrafilcon B contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day. |
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| FRESHLOOK® COLORBLENDS | Active Comparator | Phemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lotrafilcon B contact lens with color | Device | Silicone hydrogel contact lens with color |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Rating of Overall Satisfaction | Overall satisfaction, as rated by the participant on a 10-point scale, with 1 being very dissatisfied to 10 being very satisfied. The participant rated both eyes together by providing one single rating. | Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Positive Purchase Intent | As reported on a questionnaire in response to, "Assuming these lenses were at a price you would expect to pay, how likely would you be to purchase these lenses?" The binary 'positive' vs 'negative' response variable was derived from a 5-point Likert scale. Positive purchase intent is reported as the percentage of participants choosing "Definitely would purchase" or "Probably would purchase." |
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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 574 enrolled, 13 participants did not meet all inclusion/exclusion criteria and were exited as screen failures. This reporting group includes all enrolled and randomized participants (561).
Participants were recruited from 30 study centers, located in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | AIR OPTIX® COLORS | Lotrafilcon B contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day. |
| FG001 | FRESHLOOK® COLORBLENDS | Phemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The analysis population includes all randomized participants who satisfied specific Inclusion/Exclusion Criteria, did not sleep overnight in study lenses, and used only the habitual lens care during the study (552).
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| ID | Title | Description |
|---|---|---|
| BG000 | AIR OPTIX® COLORS | Lotrafilcon B contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day. |
| BG001 | FRESHLOOK® COLORBLENDS |
| 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, Customized | Number |
| 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 | Subjective Rating of Overall Satisfaction | Overall satisfaction, as rated by the participant on a 10-point scale, with 1 being very dissatisfied to 10 being very satisfied. The participant rated both eyes together by providing one single rating. | The analysis population includes all randomized participants who satisfied specific Inclusion/Exclusion Criteria, did not sleep overnight in study lenses, and used only the habitual lens care during the study. The actual sample size used in calculating the outcome measure may be smaller due to missing responses and/or visit attendance. | Posted | Mean | Standard Error | Units on a scale | Day 7 |
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Adverse Events (AE) were collected for the duration of the study (2 months). AEs were obtained as solicited comments and as observations by the study Investigator.
The analysis population includes all participants/eyes exposed to the study products. 5 participants from Test (AIR OPTIX® COLORS) and 6 participants from Control (FRESHLOOK® COLORBLENDS) were randomized but not exposed to the investigational products. Color selection and/or trial-fitting lenses were not considered study products.
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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 contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sharon Thomas, O.D., Sr. Principal Clinical Scientist | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Phemfilcon A contact lens with color | Device | Hydrogel contact lens with color |
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| Day 7 |
| Physician Decision |
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| Protocol Violation |
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| Withdrawal by Subject |
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| Randomized in Error |
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| Habitually wearing toric lens OS |
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Phemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
| BG002 | Total | Total of all reporting groups |
| participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| OG001 | FRESHLOOK® COLORBLENDS | Phemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day. |
|
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| Secondary | Positive Purchase Intent | As reported on a questionnaire in response to, "Assuming these lenses were at a price you would expect to pay, how likely would you be to purchase these lenses?" The binary 'positive' vs 'negative' response variable was derived from a 5-point Likert scale. Positive purchase intent is reported as the percentage of participants choosing "Definitely would purchase" or "Probably would purchase." | The analysis population includes all randomized participants who satisfied specific Inclusion/Exclusion Criteria, did not sleep overnight in study lenses, and used only the habitual lens care during the study. The actual sample size used in calculating the outcome measure may be smaller due to missing responses and/or visit attendance. | Posted | Number | Percentage of participants | Day 7 |
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| 0 |
| 276 |
| 0 |
| 276 |
| EG001 | FRESHLOOK® COLORBLENDS | Phemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day. | 0 | 274 | 0 | 274 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.