Trial Outcomes & Findings for A Comparison of Silicone Hydrogel Contact Lenses: AIR OPTIX® COLORS Versus AIR OPTIX® AQUA (NCT NCT01635920)
NCT ID: NCT01635920
Last Updated: 2014-03-28
Results Overview
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.
COMPLETED
NA
258 participants
Up to Day 28
2014-03-28
Participant Flow
Participants were recruited from 15 study centers located in the United States.
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).
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
125
|
126
|
|
Overall Study
COMPLETED
|
122
|
125
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Subject decision
|
2
|
0
|
Baseline Characteristics
A Comparison of Silicone Hydrogel Contact Lenses: AIR OPTIX® COLORS Versus AIR OPTIX® AQUA
Baseline characteristics by cohort
| Measure |
AIR OPTIX® COLORS
n=125 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.
|
AIR OPTIX® AQUA
n=126 Participants
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.
|
Total
n=251 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
16-17 years
|
10 participants
n=5 Participants
|
5 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Age, Customized
18-64 years
|
115 participants
n=5 Participants
|
119 participants
n=7 Participants
|
234 participants
n=5 Participants
|
|
Age, Customized
≥ 65 years
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Day 28Population: 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.
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.
Outcome measures
| Measure |
AIR OPTIX® COLORS
n=125 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.
|
AIR OPTIX® AQUA
n=126 Participants
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.
|
|---|---|---|
|
Percentage of Subjects With Same Fit in Both Eyes
Day 14 (n=121,126)
|
99.2 percentage of participants
|
100 percentage of participants
|
|
Percentage of Subjects With Same Fit in Both Eyes
Day 28 (n=122, 124)
|
99.2 percentage of participants
|
99.2 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 28Population: 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.
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.
Outcome measures
| Measure |
AIR OPTIX® COLORS
n=125 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.
|
AIR OPTIX® AQUA
n=126 Participants
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.
|
|---|---|---|
|
Subjective Rating of Overall Comfort
Day 14 (n=122, 126)
|
8.4 units on a scale
Standard Deviation 1.8
|
8.9 units on a scale
Standard Deviation 1.3
|
|
Subjective Rating of Overall Comfort
Day 28 (n=122, 125)
|
8.5 units on a scale
Standard Deviation 1.4
|
8.9 units on a scale
Standard Deviation 1.4
|
Adverse Events
AIR OPTIX® COLORS
AIR OPTIX® AQUA
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sharon Holden 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