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The purpose of this study was to evaluate the overall comfort of AIR OPTIX® COLORS compared to FRESHLOOK® COLORBLENDS in habitual wearers of the FRESHLOOK® COLORBLENDS .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AIR OPTIX® COLORS | Experimental | Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day. |
|
| FRESHLOOK® COLORBLENDS | Active Comparator | Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day. |
|
| 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 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Rating of Overall Vision | Overall vision, 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 |
| Proportion of Subjects Preferring Study Lens (Strongly or Somewhat) |
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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 370 participants enrolled and randomized, 4 did not meet inclusion/exclusion criteria, 2 were lost to follow-up, and 1 declined participation. This reporting group includes all participants exposed to the study product (363).
Participants were recruited from 24 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 in daily wear modality for 4 weeks. 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 in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The analysis population includes all participants exposed to the study product (363).
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| ID | Title | Description |
|---|---|---|
| BG000 | AIR OPTIX® COLORS | Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day. |
| BG001 | FRESHLOOK® COLORBLENDS |
| 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 | 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. | The analysis population includes all enrolled and dispensed participants who had at least one study visit after being dispensed with study lenses (N=178,185). 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. | Posted | Mean | Standard Deviation | Units on a scale | Up to Day 28 |
|
Adverse Events (AE) were collected for the duration of the study (3 months). AEs were obtained as solicited comments from subjects and as observations by the study Investigator as outlined in the study protocol.
The analysis population includes all participants exposed to the study product. An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings), whether or not related to the investigational medical device.
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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 in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal abrasion | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment | Not related |
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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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| Phemfilcon A contact lens with color | Device | Hydrogel contact lens with color. |
|
|
Participants were asked to compare the study lenses to their habitual lenses using a 5-point scale: strongly prefer study lenses, somewhat prefer study lenses, no preference, somewhat prefer habitual lenses, and strongly prefer habitual lenses, where 'study lenses' refer to either test or control depending on the treatment group. Proportion of subjects preferring study lens is reported as the percentage of participants who strongly or somewhat preferred the study lens. |
| Day 28 |
| Subject decision |
|
| Noncompliance |
|
| No longer had transportation |
|
Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 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 |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| FRESHLOOK® COLORBLENDS |
Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day. |
|
|
| Secondary | Subjective Rating of Overall Vision | Overall vision, 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. | The analysis population includes all enrolled and dispensed participants who had at least one study visit after being dispensed with study lenses (N=178,185). 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. | Posted | Mean | Standard Deviation | Units on a scale | Up to Day 28 |
|
|
|
| Secondary | Proportion of Subjects Preferring Study Lens (Strongly or Somewhat) | Participants were asked to compare the study lenses to their habitual lenses using a 5-point scale: strongly prefer study lenses, somewhat prefer study lenses, no preference, somewhat prefer habitual lenses, and strongly prefer habitual lenses, where 'study lenses' refer to either test or control depending on the treatment group. Proportion of subjects preferring study lens is reported as the percentage of participants who strongly or somewhat preferred the study lens. | The analysis population includes all enrolled and dispensed participants who had at least 1 study visit after being dispensed the study lenses. No imputation was used for missing values. | Posted | Number | Percentage of participants | Day 28 |
|
|
|
| 1 |
| 178 |
| 0 |
| 178 |
| EG001 | FRESHLOOK® COLORBLENDS | Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day. | 2 | 185 | 0 | 185 |
|
| Injury | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment | Injuries due to a car accident. Not related. |
|
| Cholecystitis infective | Infections and infestations | MedDRA (15.0) | Systematic Assessment | Not related |
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Sponsor reserves the right of prior review of any publication or presentation of information related to the study.