Trial Outcomes & Findings for AIR OPTIX® COLORS Registration Trial (NCT NCT01440322)
NCT ID: NCT01440322
Last Updated: 2014-05-08
Results Overview
Visual acuity, as assessed for each eye individually. Participant read a distance Snellen chart while wearing study lenses. The percentage of eyes with VA recorded as 20/30 or better is reported. Both eyes contributed to the percentage.
COMPLETED
NA
150 participants
Up to Month 3
2014-05-08
Participant Flow
Participants were recruited from 10 investigational centers located in the United States.
Of the 150 participants enrolled, 3 were exited from the study as screen failures prior to study product dispense. This reporting group includes all randomized and dispensed participants (147).
Participant milestones
| Measure |
AIR OPTIX® COLORS
Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
|
AIR OPTIX® AQUA
Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
|
|---|---|---|
|
Overall Study
STARTED
|
97
|
50
|
|
Overall Study
COMPLETED
|
90
|
49
|
|
Overall Study
NOT COMPLETED
|
7
|
1
|
Reasons for withdrawal
| Measure |
AIR OPTIX® COLORS
Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
|
AIR OPTIX® AQUA
Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
|
|---|---|---|
|
Overall Study
Discomfort
|
2
|
0
|
|
Overall Study
Biomicroscopy
|
1
|
0
|
|
Overall Study
Symptoms and Problems
|
1
|
0
|
|
Overall Study
Unacceptable Subjective Vision
|
1
|
0
|
|
Overall Study
Other Product Related
|
1
|
0
|
|
Overall Study
Unrelated Medical Problem
|
0
|
1
|
|
Overall Study
Other Non-Product Related
|
1
|
0
|
Baseline Characteristics
AIR OPTIX® COLORS Registration Trial
Baseline characteristics by cohort
| Measure |
AIR OPTIX® COLORS
n=100 Participants
Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
|
AIR OPTIX® AQUA
n=50 Participants
Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.0 years
STANDARD_DEVIATION 10.28 • n=5 Participants
|
31.0 years
STANDARD_DEVIATION 9.91 • n=7 Participants
|
31.0 years
STANDARD_DEVIATION 10.13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Month 3Population: The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, "n" is the number of eyes with non-missing values at the specific time point for each arm group, used as the denominator for percentage calculation.
Visual acuity, as assessed for each eye individually. Participant read a distance Snellen chart while wearing study lenses. The percentage of eyes with VA recorded as 20/30 or better is reported. Both eyes contributed to the percentage.
Outcome measures
| Measure |
AIR OPTIX® COLORS
n=180 Eyes
Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
|
AIR OPTIX® AQUA
n=98 Eyes
Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
|
|---|---|---|
|
Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better)
Dispense (n=180,98)
|
100.0 Percentage of eyes
|
100.0 Percentage of eyes
|
|
Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better)
Week 1 (n=180,98)
|
100.0 Percentage of eyes
|
98.0 Percentage of eyes
|
|
Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better)
Week 2 (n=180,96)
|
100.0 Percentage of eyes
|
97.9 Percentage of eyes
|
|
Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better)
Month 1 (n=180,98)
|
100.0 Percentage of eyes
|
100.0 Percentage of eyes
|
|
Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better)
Month 2 (n=179,98)
|
100.0 Percentage of eyes
|
100.0 Percentage of eyes
|
|
Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better)
Month 3 (n=178,98)
|
100.0 Percentage of eyes
|
100.0 Percentage of eyes
|
SECONDARY outcome
Timeframe: Up to Month 3Population: The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, "n" is the number of participants with non-missing values at the specific time point for each arm group.
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.
Outcome measures
| Measure |
AIR OPTIX® COLORS
n=90 Participants
Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
|
AIR OPTIX® AQUA
n=49 Participants
Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
|
|---|---|---|
|
Subjective Rating of Overall Vision
Dispense (n=90,49)
|
8.3 Units on a scale
Standard Deviation 1.7
|
9.5 Units on a scale
Standard Deviation 0.9
|
|
Subjective Rating of Overall Vision
Week 1 (n=90,49)
|
8.0 Units on a scale
Standard Deviation 2.1
|
9.4 Units on a scale
Standard Deviation 0.9
|
|
Subjective Rating of Overall Vision
Week 2 (n=90,48)
|
8.1 Units on a scale
Standard Deviation 2.0
|
9.4 Units on a scale
Standard Deviation 0.9
|
|
Subjective Rating of Overall Vision
Month 1 (n=90,49)
|
8.4 Units on a scale
Standard Deviation 1.9
|
9.3 Units on a scale
Standard Deviation 0.9
|
|
Subjective Rating of Overall Vision
Month 2 (n=90,49)
|
8.5 Units on a scale
Standard Deviation 1.8
|
9.3 Units on a scale
Standard Deviation 1.0
|
|
Subjective Rating of Overall Vision
Month 3 (n=90,49)
|
8.4 Units on a scale
Standard Deviation 1.8
|
9.3 Units on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Up to Month 3Population: The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, "n" is the number of participants with non-missing values at the specific time point for each arm group.
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=90 Participants
Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
|
AIR OPTIX® AQUA
n=49 Participants
Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
|
|---|---|---|
|
Subjective Rating of Overall Comfort
Dispense (n=90,49)
|
9.1 Units on a scale
Standard Deviation 1.5
|
9.2 Units on a scale
Standard Deviation 0.9
|
|
Subjective Rating of Overall Comfort
Week 1 (n=90,49)
|
8.3 Units on a scale
Standard Deviation 1.9
|
9.0 Units on a scale
Standard Deviation 1.2
|
|
Subjective Rating of Overall Comfort
Week 2 (n=90,48)
|
8.6 Units on a scale
Standard Deviation 1.7
|
9.3 Units on a scale
Standard Deviation 0.8
|
|
Subjective Rating of Overall Comfort
Month 1 (n=90,49)
|
8.4 Units on a scale
Standard Deviation 1.8
|
8.9 Units on a scale
Standard Deviation 1.1
|
|
Subjective Rating of Overall Comfort
Month 2 (n=90,49)
|
8.5 Units on a scale
Standard Deviation 1.8
|
8.8 Units on a scale
Standard Deviation 1.1
|
|
Subjective Rating of Overall Comfort
Month 3 (n=90,49)
|
8.6 Units on a scale
Standard Deviation 1.7
|
8.9 Units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Up to Month 3Population: The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, "n" is the number of participants with non-missing values at the specific time point for each arm group.
Overall handling, as rated by the participant on a 10-point scale, with 1 being difficult and 10 being easy. The participant rated both eyes together by providing one single rating.
Outcome measures
| Measure |
AIR OPTIX® COLORS
n=90 Participants
Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
|
AIR OPTIX® AQUA
n=49 Participants
Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
|
|---|---|---|
|
Subjective Rating of Overall Handling
Month 2 (n=90,49)
|
9.4 Units on a scale
Standard Deviation 1.2
|
9.4 Units on a scale
Standard Deviation 0.9
|
|
Subjective Rating of Overall Handling
Dispense (n=90,49)
|
9.3 Units on a scale
Standard Deviation 1.3
|
9.5 Units on a scale
Standard Deviation 0.8
|
|
Subjective Rating of Overall Handling
Week 1 (n=90,49)
|
9.4 Units on a scale
Standard Deviation 1.0
|
9.2 Units on a scale
Standard Deviation 1.2
|
|
Subjective Rating of Overall Handling
Week 2 (n=90,48)
|
9.4 Units on a scale
Standard Deviation 1.0
|
9.4 Units on a scale
Standard Deviation 0.9
|
|
Subjective Rating of Overall Handling
Month 1 (n=90,49)
|
9.5 Units on a scale
Standard Deviation 0.9
|
9.4 Units on a scale
Standard Deviation 0.8
|
|
Subjective Rating of Overall Handling
Month 3 (n=90,49)
|
9.4 Units on a scale
Standard Deviation 1.0
|
9.3 Units on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Up to Month 3Population: The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, "n" is the number of eyes with non-missing values at the specific time point for each arm group, used as the denominator for percentage calculation.
Lens fit, as assessed by the investigator for each eye individually. Lens fit was rated on a 5-point scale: 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, -2=unacceptably tight. The combined percentage of lenses assessed as "optimal," "acceptably loose," or "acceptably tight" is reported. Lenses from both eyes contributed to the percentage.
Outcome measures
| Measure |
AIR OPTIX® COLORS
n=180 Eyes
Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
|
AIR OPTIX® AQUA
n=98 Eyes
Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
|
|---|---|---|
|
Lens Fit (Optimal, Acceptably Loose, Acceptably Tight)
Month 2 (n=179,98)
|
100.0 Percentage of lenses
|
100.0 Percentage of lenses
|
|
Lens Fit (Optimal, Acceptably Loose, Acceptably Tight)
Dispense (n=180,98)
|
100.0 Percentage of lenses
|
100.0 Percentage of lenses
|
|
Lens Fit (Optimal, Acceptably Loose, Acceptably Tight)
Week 1 (n=180,98)
|
100.0 Percentage of lenses
|
100.0 Percentage of lenses
|
|
Lens Fit (Optimal, Acceptably Loose, Acceptably Tight)
Week 2 (n=180,96)
|
100.0 Percentage of lenses
|
100.0 Percentage of lenses
|
|
Lens Fit (Optimal, Acceptably Loose, Acceptably Tight)
Month 1 (n=180,98)
|
100.0 Percentage of lenses
|
100.0 Percentage of lenses
|
|
Lens Fit (Optimal, Acceptably Loose, Acceptably Tight)
Month 3 (n=180,98)
|
100.0 Percentage of lenses
|
100.0 Percentage of lenses
|
SECONDARY outcome
Timeframe: Up to Month 3Population: The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, "n" is the number of eyes with non-missing values at the specific time point for each arm group, used as the denominator for percentage calculation.
Lens centration, as assessed by the investigator for each eye individually. Lens centration was rated on a 5-point scale: 0=centered, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as "centered" or "slight decentration" is reported. Lenses from both eyes contributed to the percentage.
Outcome measures
| Measure |
AIR OPTIX® COLORS
n=180 Eyes
Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
|
AIR OPTIX® AQUA
n=98 Eyes
Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
|
|---|---|---|
|
Lens Centration (Centered, Slight Decentration)
Week 1 (n=180,98)
|
100.0 Percentage of lenses
|
100.0 Percentage of lenses
|
|
Lens Centration (Centered, Slight Decentration)
Week 2 (n=180,96)
|
100.0 Percentage of lenses
|
100.0 Percentage of lenses
|
|
Lens Centration (Centered, Slight Decentration)
Dispense (n=180,98)
|
100.0 Percentage of lenses
|
100.0 Percentage of lenses
|
|
Lens Centration (Centered, Slight Decentration)
Month 1 (n=180,98)
|
100.0 Percentage of lenses
|
100.0 Percentage of lenses
|
|
Lens Centration (Centered, Slight Decentration)
Month 2 (n=179,98)
|
98.3 Percentage of lenses
|
100.0 Percentage of lenses
|
|
Lens Centration (Centered, Slight Decentration)
Month 3 (n=180,98)
|
100.0 Percentage of lenses
|
100.0 Percentage of lenses
|
SECONDARY outcome
Timeframe: Up to Month 3Population: The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, "n" is the number of eyes with non-missing values at the specific time point for each arm group, used as the denominator for percentage calculation.
Dry areas/non-wetting (i.e., assessment of the disruption of the front surface wettability of the contact lens), as assessed by the investigator for each eye individually. Dry areas/non-wetting was rated on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as "none" or "very slight" is reported. Lenses from both eyes contributed to the percentage.
Outcome measures
| Measure |
AIR OPTIX® COLORS
n=180 Eyes
Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
|
AIR OPTIX® AQUA
n=98 Eyes
Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
|
|---|---|---|
|
Dry Areas/Non-Wetting (None, Very Slight)
Dispense (n=180,98)
|
100.0 Percentage of lenses
|
100.0 Percentage of lenses
|
|
Dry Areas/Non-Wetting (None, Very Slight)
Week 1 (n=180,98)
|
100.0 Percentage of lenses
|
99.0 Percentage of lenses
|
|
Dry Areas/Non-Wetting (None, Very Slight)
Week 2 (n=180,96)
|
99.4 Percentage of lenses
|
99.0 Percentage of lenses
|
|
Dry Areas/Non-Wetting (None, Very Slight)
Month 1 (n=180,98)
|
100.0 Percentage of lenses
|
100.0 Percentage of lenses
|
|
Dry Areas/Non-Wetting (None, Very Slight)
Month 2 (n=179,98)
|
100.0 Percentage of lenses
|
100.0 Percentage of lenses
|
|
Dry Areas/Non-Wetting (None, Very Slight)
Month 3 (n=180,98)
|
100.0 Percentage of lenses
|
100.0 Percentage of lenses
|
SECONDARY outcome
Timeframe: Up to Month 3Population: The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, "n" is the number of eyes with non-missing values at the specific time point for each arm group, used as the denominator for percentage calculation.
Front surface deposits on the contact lens, as assessed by the investigator for each eye individually. Front surface deposits were rated on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as "none" or "very slight" is reported. Lenses from both eyes contributed to the percentage.
Outcome measures
| Measure |
AIR OPTIX® COLORS
n=180 Eyes
Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
|
AIR OPTIX® AQUA
n=98 Eyes
Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
|
|---|---|---|
|
Front Surface Deposits (None, Very Slight)
Week 2 (n=180,96)
|
97.8 Percentage of lenses
|
99.0 Percentage of lenses
|
|
Front Surface Deposits (None, Very Slight)
Dispense (n=180,98)
|
100.0 Percentage of lenses
|
100.0 Percentage of lenses
|
|
Front Surface Deposits (None, Very Slight)
Week 1 (n=180,98)
|
96.7 Percentage of lenses
|
98.0 Percentage of lenses
|
|
Front Surface Deposits (None, Very Slight)
Month 1 (n=180,98)
|
96.7 Percentage of lenses
|
95.9 Percentage of lenses
|
|
Front Surface Deposits (None, Very Slight)
Month 2 (n=179,98)
|
97.2 Percentage of lenses
|
98.0 Percentage of lenses
|
|
Front Surface Deposits (None, Very Slight)
Month 3 (n=180,98)
|
94.4 Percentage of lenses
|
98.0 Percentage of lenses
|
SECONDARY outcome
Timeframe: Up to Month 3Population: The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, "n" is the number of eyes with non-missing values at the specific time point for each arm group, used as the denominator for percentage calculation.
Back surface deposits on the contact lens, as assessed by the investigator for each eye individually. Back surface deposits were rated on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as "none" or "very slight" is reported. Lenses from both eyes contributed to the percentage.
Outcome measures
| Measure |
AIR OPTIX® COLORS
n=180 Eyes
Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
|
AIR OPTIX® AQUA
n=98 Eyes
Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
|
|---|---|---|
|
Back Surface Deposits (None, Very Slight)
Dispense (n=180,98)
|
100.0 Percentage of lenses
|
99.0 Percentage of lenses
|
|
Back Surface Deposits (None, Very Slight)
Week 1 (n=180,98)
|
100.0 Percentage of lenses
|
100.0 Percentage of lenses
|
|
Back Surface Deposits (None, Very Slight)
Week 2 (n=180,96)
|
99.4 Percentage of lenses
|
100.0 Percentage of lenses
|
|
Back Surface Deposits (None, Very Slight)
Month 1 (n=180,98)
|
100.0 Percentage of lenses
|
95.9 Percentage of lenses
|
|
Back Surface Deposits (None, Very Slight)
Month 2 (n=179,98)
|
99.4 Percentage of lenses
|
100.0 Percentage of lenses
|
|
Back Surface Deposits (None, Very Slight)
Month 3 (n=180,98)
|
99.4 Percentage of lenses
|
100.0 Percentage of lenses
|
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, 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