Trial Outcomes & Findings for A Comparison of Two Color Contact Lenses in Habitual Clear Contact Lens Wearers (NCT NCT02175199)
NCT ID: NCT02175199
Last Updated: 2015-10-14
Results Overview
Subject indicated agreement with the following statement, "These lenses provided the same excellent comfort at the end of the month as they did at the beginning of the month" using a 4-point Likert scale, where 1=Strongly disagree, 2=Disagree; 3=Agree; 4=Strongly agree. The Top 2 responses (agree, strongly agree) were calculated and reported as a percentage of all responses. Both eyes were rated together. This outcome measure was prespecified for the AIR OPTIX COLORS arm only.
COMPLETED
NA
151 participants
Day 30
2015-10-14
Participant Flow
Subjects were recruited from 10 Study Centers located in the US.
Of the 151 enrolled, 1 subject was exited as a screen failure prior to randomization. This reporting group includes all randomized subjects (150).
Participant milestones
| Measure |
AIR OPTIX COLORS
Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days.
|
FreshLook COLORBLENDS
Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days with a 2-week replacement.
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
76
|
|
Overall Study
Dispensed
|
72
|
74
|
|
Overall Study
COMPLETED
|
71
|
71
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
AIR OPTIX COLORS
Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days.
|
FreshLook COLORBLENDS
Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days with a 2-week replacement.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
5
|
|
Overall Study
Randomized in Error
|
1
|
0
|
|
Overall Study
Sponsor Decision
|
1
|
0
|
Baseline Characteristics
A Comparison of Two Color Contact Lenses in Habitual Clear Contact Lens Wearers
Baseline characteristics by cohort
| Measure |
AIR OPTIX COLORS
n=72 Participants
Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days.
|
FreshLook COLORBLENDS
n=74 Participants
Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days with a 2-week replacement.
|
Total
n=146 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.9 years
STANDARD_DEVIATION 7.91 • n=5 Participants
|
29.4 years
STANDARD_DEVIATION 7.62 • n=7 Participants
|
29.7 years
STANDARD_DEVIATION 7.74 • n=5 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 30Population: This analysis population includes all randomized subjects excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).
Subject indicated agreement with the following statement, "These lenses provided the same excellent comfort at the end of the month as they did at the beginning of the month" using a 4-point Likert scale, where 1=Strongly disagree, 2=Disagree; 3=Agree; 4=Strongly agree. The Top 2 responses (agree, strongly agree) were calculated and reported as a percentage of all responses. Both eyes were rated together. This outcome measure was prespecified for the AIR OPTIX COLORS arm only.
Outcome measures
| Measure |
AIR OPTIX COLORS
n=70 Participants
Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days.
|
FreshLook COLORBLENDS
Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days with a 2-week replacement.
|
|---|---|---|
|
Lens Comfort Likert Response at Day 30
|
81.4 percentage of subjects
|
—
|
SECONDARY outcome
Timeframe: Day 14Population: This analysis population includes all randomized subjects with data at visit excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).
Subject indicated agreement with the following statement, "These lenses provided the same excellent comfort at the end of two weeks as they did at the beginning of the two weeks" using a 4-point Likert scale, where 1=Strongly disagree, 2=Disagree; 3=Agree; 4=Strongly agree. The Top 2 responses (agree, strongly agree) were calculated and reported as a percentage of all responses. Both eyes were rated together. This outcome measure is prespecified for the AIR OPTIX COLORS arm only.
Outcome measures
| Measure |
AIR OPTIX COLORS
n=69 Participants
Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days.
|
FreshLook COLORBLENDS
Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days with a 2-week replacement.
|
|---|---|---|
|
Lens Comfort Likert Response at Day 14
|
89.9 percentage of subjects
|
—
|
SECONDARY outcome
Timeframe: Day 30Population: This analysis population includes all randomized subjects with data at visit excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).
Subject was instructed, "Please rate your comfort with the study lenses," using a scale from 1-10, where 1=poor and 10=excellent. Both eyes were rated together.
Outcome measures
| Measure |
AIR OPTIX COLORS
n=70 Participants
Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days.
|
FreshLook COLORBLENDS
n=70 Participants
Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days with a 2-week replacement.
|
|---|---|---|
|
Lens Comfort 1-10 Scale Response
|
8.0 units on a scale
Standard Deviation 1.99
|
7.3 units on a scale
Standard Deviation 2.19
|
Adverse Events
Pre-treatment
AIR OPTIX COLORS
FreshLook COLORBLENDS
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Global Brand Lead, GCRA, Vision Care
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