Trial Outcomes & Findings for Study of the Cell Response in the Tear Film After Overnight Contact Lens Wear (NCT NCT01379768)
NCT ID: NCT01379768
Last Updated: 2013-03-08
Results Overview
A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA). Different types of white blood cells (leukocytes) were identified, which included neutrophils, monocytes, and lymphocytes. The total amount of leukocytes for contact lens wearers and non-lens wearers is presented. Potential differences in leukocyte count between lens wearers and non-lens wearers may indicate a different immune response.
COMPLETED
NA
65 participants
Week 5
2013-03-08
Participant Flow
Study participants were recruited from one study center located in Canada.
Participant milestones
| Measure |
Lotrafilcon A
Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
|
Lotrafilcon B
Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
|
No Lens Wear
No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
|
|---|---|---|---|
|
Overall Study
STARTED
|
23
|
22
|
20
|
|
Overall Study
COMPLETED
|
20
|
21
|
20
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
0
|
Reasons for withdrawal
| Measure |
Lotrafilcon A
Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
|
Lotrafilcon B
Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
|
No Lens Wear
No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
0
|
Baseline Characteristics
Study of the Cell Response in the Tear Film After Overnight Contact Lens Wear
Baseline characteristics by cohort
| Measure |
Lotrafilcon A
n=23 Participants
Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
|
Lotrafilcon B
n=22 Participants
Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
|
No Lens Wear
n=20 Participants
No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
|
22 years
n=5 Participants
|
23.5 years
n=7 Participants
|
23.5 years
n=5 Participants
|
23 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
23 participants
n=5 Participants
|
22 participants
n=7 Participants
|
20 participants
n=5 Participants
|
65 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 5Population: This reporting group includes all participants who completed the study per protocol.
A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA). Different types of white blood cells (leukocytes) were identified, which included neutrophils, monocytes, and lymphocytes. The total amount of leukocytes for contact lens wearers and non-lens wearers is presented. Potential differences in leukocyte count between lens wearers and non-lens wearers may indicate a different immune response.
Outcome measures
| Measure |
Lotrafilcon A
n=20 Participants
Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
|
Lotrafilcon B
n=19 Participants
Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
|
No Lens Wear
n=20 Participants
No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
|
|---|---|---|---|
|
Leukocyte Population
|
583187 Leukocytes
Standard Deviation 832636
|
420345 Leukocytes
Standard Deviation 355940
|
738140 Leukocytes
Standard Deviation 609853
|
PRIMARY outcome
Timeframe: Week 5Population: This reporting group includes all participants who completed the study per protocol.
A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. CD54 is a protein typically found in the cell membrane of leukocytes, which up-regulates during inflammation and promotes cell adhesion. Cell adhesion response is reported as a ratio of stimulated to non-stimulated samples.
Outcome measures
| Measure |
Lotrafilcon A
n=20 Participants
Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
|
Lotrafilcon B
n=18 Participants
Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
|
No Lens Wear
n=19 Participants
No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
|
|---|---|---|---|
|
Relative Cell Adhesion Response of Polymorphonuclear Leukocytes (PMNs)
|
1.1 Ratio
Standard Deviation 0.2
|
1.2 Ratio
Standard Deviation 0.2
|
1.1 Ratio
Standard Deviation 0.1
|
PRIMARY outcome
Timeframe: Week 5Population: This reporting group includes all participants who completed the study per protocol.
A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. Oxidative response is reported as a ratio of activated to non-activated samples. DCF (dichlorofluorescein diacetate) is a molecular probe that measures the oxidative burst. Upon stimulation, the PMNs synthesize reactive oxygen species, such as superoxide or hydrogen peroxide, which is detected by the probe. Differences in the oxidative response between contact lens wearers and non-lens wearers is indicated by a shift in the ratio (stimulated/unstimulated).
Outcome measures
| Measure |
Lotrafilcon A
n=20 Participants
Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
|
Lotrafilcon B
n=19 Participants
Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
|
No Lens Wear
n=20 Participants
No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
|
|---|---|---|---|
|
Relative Oxidative Response of Polymorphonuclear Leukocytes (PMNs)
|
1.2 Ratio
Standard Deviation 0.5
|
1.7 Ratio
Standard Deviation 1.1
|
1.3 Ratio
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: Week 1, Week 5Population: This reporting group includes all participants who completed the study per protocol.
A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA). Different types of white blood cells (leukocytes) were identified, which included neutrophils, monocytes, and lymphocytes. The difference between total leukocytes for contact lens wearers and non-lens wearers (Week 5 minus Week 1) is presented.
Outcome measures
| Measure |
Lotrafilcon A
n=19 Participants
Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
|
Lotrafilcon B
n=19 Participants
Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
|
No Lens Wear
n=19 Participants
No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
|
|---|---|---|---|
|
Change From Week 1 in Leukocyte Population at Week 5
|
-1377 Leukocytes
Standard Deviation 453,119
|
-95301 Leukocytes
Standard Deviation 632752
|
122316 Leukocytes
Standard Deviation 519976
|
PRIMARY outcome
Timeframe: Week 1, Week 5Population: This reporting group includes all participants who completed the study per protocol.
A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. Cell adhesion response is reported as a ratio of activated to non-activated samples. The difference between the ratio data for contact lens wearers and non-lens wearers (Week 5 minus Week 1) is presented.
Outcome measures
| Measure |
Lotrafilcon A
n=18 Participants
Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
|
Lotrafilcon B
n=15 Participants
Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
|
No Lens Wear
n=16 Participants
No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
|
|---|---|---|---|
|
Change From 1 Week in Relative Cell Adhesion Response of PMNs at Week 5
|
-0.01 Ratio
Standard Deviation 0.23
|
0.00 Ratio
Standard Deviation 0.24
|
-0.01 Ratio
Standard Deviation 0.20
|
PRIMARY outcome
Timeframe: Week 1, Week 5Population: This reporting group includes all participants who completed the study per protocol.
A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. Oxidative response is reported as a ratio of activated to non-activated samples. The difference between the ratio data for contact lens wearers and non-lens wearers (Week 5 minus Week 1) is presented.
Outcome measures
| Measure |
Lotrafilcon A
n=19 Participants
Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
|
Lotrafilcon B
n=18 Participants
Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
|
No Lens Wear
n=19 Participants
No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
|
|---|---|---|---|
|
Change From Week 1 in Relative Oxidative Response of PMNs at Week 5
|
0.05 Ratio
Standard Deviation 0.94
|
0.24 Ratio
Standard Deviation 1.20
|
-0.19 Ratio
Standard Deviation 0.58
|
Adverse Events
Lotrafilcon A
Lotrafilcon B
No Lens Wear
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director of Alcon Clinical, Atlanta
Alcon Research
Results disclosure agreements
- Principal investigator is a sponsor employee For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must obtain sponsor's written consent before discussing, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.
- Publication restrictions are in place
Restriction type: OTHER