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The purpose of this study was to compare the overall fit of AIR OPTIX® COLORS to AIR OPTIX® AQUA contact lenses.
Eligible participants were randomized at Visit 1 (Screening) to receive 1 of the 2 investigational products (1:1 assignment). Between Visit 1 and Visit 2, participants wore their habitual AIR OPTIX® AQUA lenses. Investigational products were dispensed at Visit 2 (Baseline), after which participants were asked to return for 2 additional visits: Visit 3 (Day 14) and Visit 4 (Day 28).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AIR OPTIX® COLORS | Experimental | Lotrafilcon B contact lens with color worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks. |
|
| AIR OPTIX® AQUA | Active Comparator | Lotrafilcon B contact lens worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks. |
|
| 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 |
|---|---|---|
| Percentage of Subjects With Same Fit in Both Eyes | Lens fit was assessed by the investigator for each eye using a biomicroscope (slit lamp), which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight. "Same fit" was defined as an eye that achieved an acceptable or optimal overall lens fit with the study lens, that was also within one grade of the value observed on the same eye with the habitual lens at the baseline visit. | Up to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Rating of Overall Comfort | Overall comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating. | Up to Day 28 |
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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 258 participants enrolled, 7 participants did not receive study lenses. This reporting group includes all enrolled and randomized participants who received study lenses (251).
Participants were recruited from 15 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 bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks. |
| FG001 | AIR OPTIX® AQUA | Lotrafilcon B contact lens worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The analysis population includes all enrolled and randomized participants who received study lenses (251).
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| ID | Title | Description |
|---|---|---|
| BG000 | AIR OPTIX® COLORS | Lotrafilcon B contact lens with color worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks. |
| BG001 | AIR OPTIX® AQUA |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Percentage of Subjects With Same Fit in Both Eyes | Lens fit was assessed by the investigator for each eye using a biomicroscope (slit lamp), which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight. "Same fit" was defined as an eye that achieved an acceptable or optimal overall lens fit with the study lens, that was also within one grade of the value observed on the same eye with the habitual lens at the baseline visit. | ITT: All enrolled and dispensed participants who had at least one study visit after being dispensed with study lenses (N=125,126). No imputation was used for the missing values. Here, "n" is the number of participants with non-missing values at the specific time point for each arm group, respectively. | Posted | Number | percentage of participants | Up to Day 28 |
|
Adverse Events (AE) were collected after signing the informed consent, and reported for the duration of the study (2 months).
AEs were defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. The analysis population includes all enrolled and randomized participants who received study lenses.
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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 bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sharon Holden 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 |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Lotrafilcon B contact lens | Device | Silicone hydrogel contact lens |
|
|
| Subject decision |
|
Lotrafilcon B contact lens worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Lotrafilcon B contact lens with color worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks. |
| OG001 | AIR OPTIX® AQUA | Lotrafilcon B contact lens worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks. |
|
|
| Secondary | Subjective Rating of Overall Comfort | Overall comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating. | ITT: All enrolled and dispensed participants who had at least one study visit after being dispensed with study lenses (N=125,126). No imputation was used for the missing values. Here, "n" is the number of participants with non-missing values at the specific time point for each arm group, respectively. | Posted | Mean | Standard Deviation | units on a scale | Up to Day 28 |
|
|
|
| 0 |
| 125 |
| 0 |
| 125 |
| EG001 | AIR OPTIX® AQUA | Lotrafilcon B contact lens worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks. | 0 | 126 | 0 | 126 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.