Trial Outcomes & Findings for A Comparison of Two Color Contact Lenses in Habitual Clear Contact Lens Wearers (NCT NCT01782482)
NCT ID: NCT01782482
Last Updated: 2014-05-09
Results Overview
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.
COMPLETED
NA
574 participants
Day 7
2014-05-09
Participant Flow
Participants were recruited from 30 study centers, located in the United States.
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).
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
281
|
280
|
|
Overall Study
COMPLETED
|
271
|
270
|
|
Overall Study
NOT COMPLETED
|
10
|
10
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Randomized in Error
|
2
|
2
|
|
Overall Study
Habitually wearing toric lens OS
|
0
|
1
|
Baseline Characteristics
A Comparison of Two Color Contact Lenses in Habitual Clear Contact Lens Wearers
Baseline characteristics by cohort
| Measure |
AIR OPTIX® COLORS
n=278 Participants
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.
|
FRESHLOOK® COLORBLENDS
n=274 Participants
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.
|
Total
n=552 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
16-17 years
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Age, Customized
18-64 years
|
267 participants
n=5 Participants
|
263 participants
n=7 Participants
|
530 participants
n=5 Participants
|
|
Age, Customized
≥65 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
247 Participants
n=5 Participants
|
254 Participants
n=7 Participants
|
501 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 7Population: 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.
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.
Outcome measures
| Measure |
AIR OPTIX® COLORS
n=278 Participants
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.
|
FRESHLOOK® COLORBLENDS
n=274 Participants
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.
|
|---|---|---|
|
Subjective Rating of Overall Satisfaction
|
7.45 Units on a scale
Standard Error 0.17
|
6.91 Units on a scale
Standard Error 0.17
|
SECONDARY outcome
Timeframe: Day 7Population: 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.
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."
Outcome measures
| Measure |
AIR OPTIX® COLORS
n=278 Participants
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.
|
FRESHLOOK® COLORBLENDS
n=274 Participants
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.
|
|---|---|---|
|
Positive Purchase Intent
|
51.7 Percentage of participants
|
42.5 Percentage of participants
|
Adverse Events
AIR OPTIX® COLORS
FRESHLOOK® COLORBLENDS
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sharon Thomas, O.D., Sr. Principal Clinical Scientist
Alcon Research, Ltd.
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER