Trial Outcomes & Findings for Clinical and Laboratory Study of Lysozyme Deposition on Daily Disposable Contact Lenses (NCT NCT02365298)
NCT ID: NCT02365298
Last Updated: 2018-06-19
Results Overview
Measurement will be taken after the subject has worn the lenses for a full seven hours
COMPLETED
NA
28 participants
2 wks after baseline
2018-06-19
Participant Flow
Participant milestones
| Measure |
Etafilcon a /Nelfilcon A
Subjects that were randomized to receive the etafilcon A lens first, and then to receive the nelfilcon A lens second.
|
Nelfilcon A / Etafilcon A
Subjects that were randomized to receive the nelfilcon A lens first, and then to receive the etafilcon A lens second.
|
|---|---|---|
|
Period 1
STARTED
|
14
|
14
|
|
Period 1
COMPLETED
|
14
|
14
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
14
|
14
|
|
Period 2
COMPLETED
|
12
|
12
|
|
Period 2
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Etafilcon a /Nelfilcon A
Subjects that were randomized to receive the etafilcon A lens first, and then to receive the nelfilcon A lens second.
|
Nelfilcon A / Etafilcon A
Subjects that were randomized to receive the nelfilcon A lens first, and then to receive the etafilcon A lens second.
|
|---|---|---|
|
Period 2
incorrect Rx dispensed
|
1
|
0
|
|
Period 2
Discontinued at request of Sponsor
|
1
|
0
|
|
Period 2
Test Article longer available
|
0
|
1
|
|
Period 2
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Clinical and Laboratory Study of Lysozyme Deposition on Daily Disposable Contact Lenses
Baseline characteristics by cohort
| Measure |
All Dispensed Subjects
n=28 Participants
All subjects that were dispensed a study lens.
|
|---|---|
|
Age, Continuous
|
23.3 years
STANDARD_DEVIATION 4.79 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 wks after baselinePopulation: All subjects that completed all study visits without a major protocol deviation.
Measurement will be taken after the subject has worn the lenses for a full seven hours
Outcome measures
| Measure |
Etafilcon A
n=24 Participants
Subjects that wore the etafilcon A lens in either the first or second period of the study.
|
Nelfilcon A
n=24 Participants
Subjects that wore the nelfilcon A lens in either the first or second period of the study.
|
|---|---|---|
|
Total Protein and Total Lysosome Deposits
Total Lysozyme
|
294.58 (ug/lens)
Standard Deviation 113.855
|
1.68 (ug/lens)
Standard Deviation 0.975
|
|
Total Protein and Total Lysosome Deposits
Active Lysozyme
|
244.00 (ug/lens)
Standard Deviation 87.325
|
0.93 (ug/lens)
Standard Deviation 0.650
|
|
Total Protein and Total Lysosome Deposits
Total Proteins
|
482.06 (ug/lens)
Standard Deviation 139.196
|
6.46 (ug/lens)
Standard Deviation 3.953
|
PRIMARY outcome
Timeframe: 6 wks after baselinePopulation: Subjects that completed all study visits without a major protocol deviation. During the 2nd period subjects continued wearing the current lens that they were randomized to for an additional 6 weeks of wear.
Measurement will be taken after the subject has worn the lenses for a full seven hours
Outcome measures
| Measure |
Etafilcon A
n=12 Participants
Subjects that wore the etafilcon A lens in either the first or second period of the study.
|
Nelfilcon A
n=11 Participants
Subjects that wore the nelfilcon A lens in either the first or second period of the study.
|
|---|---|---|
|
Total Protein and Total Lysosome Deposits
Total Lysozyme
|
349.00 (ug/lens)
Standard Deviation 58.845
|
2.26 (ug/lens)
Standard Deviation 1.460
|
|
Total Protein and Total Lysosome Deposits
Active Lysozyme
|
263.92 (ug/lens)
Standard Deviation 38.562
|
1.13 (ug/lens)
Standard Deviation 0.538
|
|
Total Protein and Total Lysosome Deposits
Total Proteins
|
473.58 (ug/lens)
Standard Deviation 131.432
|
7.46 (ug/lens)
Standard Deviation 4.151
|
PRIMARY outcome
Timeframe: 12 wks after baselinePopulation: All subjects that completed all study visits without a major protocol deviation.During the 2nd period subjects continued wearing the current lens that they were randomized to for an additional 6 weeks of wear.
Measurement will be taken after the subject has worn the lenses for a full seven hours
Outcome measures
| Measure |
Etafilcon A
n=12 Participants
Subjects that wore the etafilcon A lens in either the first or second period of the study.
|
Nelfilcon A
n=12 Participants
Subjects that wore the nelfilcon A lens in either the first or second period of the study.
|
|---|---|---|
|
Total Protein and Lysosome Deposits
Total Lysozyme
|
289.17 (ug/lens)
Standard Deviation 78.838
|
1.58 (ug/lens)
Standard Deviation 0.851
|
|
Total Protein and Lysosome Deposits
Active Lysozymes
|
242.75 (ug/lens)
Standard Deviation 57.974
|
1.01 (ug/lens)
Standard Deviation 0.567
|
|
Total Protein and Lysosome Deposits
Total Proteins
|
394.42 (ug/lens)
Standard Deviation 122.302
|
5.87 (ug/lens)
Standard Deviation 3.181
|
PRIMARY outcome
Timeframe: 2 wks after baselinePopulation: Subjects that completed all study visits without a major protocol deviation. All 24 subjects completed the study, however in some subjects the concentration of cytokine levels were below detectable limits in the tear film sample and could not be analyzed.
Measured cytokines: IL-1β, IL-2, IL-6, IL-8, IL-10, IL-12, IL-13, and TNF-alpha Measurement will be taken after the subject has worn the lenses for a full seven hours.
Outcome measures
| Measure |
Etafilcon A
n=23 Participants
Subjects that wore the etafilcon A lens in either the first or second period of the study.
|
Nelfilcon A
n=24 Participants
Subjects that wore the nelfilcon A lens in either the first or second period of the study.
|
|---|---|---|
|
Quantity of Cytokines and Albumin in Tear Fluid
IL-10
|
2.02 (pg/ml)
Standard Deviation 1.879
|
1.64 (pg/ml)
Standard Deviation 1.389
|
|
Quantity of Cytokines and Albumin in Tear Fluid
IL-12
|
2.72 (pg/ml)
Standard Deviation 5.218
|
2.25 (pg/ml)
Standard Deviation 2.685
|
|
Quantity of Cytokines and Albumin in Tear Fluid
TFN-a
|
1.20 (pg/ml)
Standard Deviation 0.528
|
1.17 (pg/ml)
Standard Deviation 1.095
|
|
Quantity of Cytokines and Albumin in Tear Fluid
IL-1B
|
1.70 (pg/ml)
Standard Deviation 1.810
|
2.32 (pg/ml)
Standard Deviation 3.023
|
|
Quantity of Cytokines and Albumin in Tear Fluid
IL-2
|
1.19 (pg/ml)
Standard Deviation 0.841
|
1.49 (pg/ml)
Standard Deviation 1.770
|
|
Quantity of Cytokines and Albumin in Tear Fluid
IL-6
|
12.32 (pg/ml)
Standard Deviation 11.756
|
15.03 (pg/ml)
Standard Deviation 18.835
|
|
Quantity of Cytokines and Albumin in Tear Fluid
IL-8
|
466.32 (pg/ml)
Standard Deviation 291.109
|
472.91 (pg/ml)
Standard Deviation 273.444
|
|
Quantity of Cytokines and Albumin in Tear Fluid
IL-13
|
29.62 (pg/ml)
Standard Deviation 19.510
|
27.23 (pg/ml)
Standard Deviation 23.651
|
PRIMARY outcome
Timeframe: 6 wks after baselinePopulation: All subjects that completed all study visits without a major protocol deviation. All 12 subjects completed the study, however in some subjects the concentration of cytokine levels were below detectable limits in the tear film sample and could not be analyzed.
Measured cytokines: IL-1β, IL-2, IL-6, IL-8, IL-10, IL-12, IL-13, and TNF-alpha. Measurement will be taken after the subject has worn the lenses for a full seven hours. During the 2nd period subjects continued wearing the current lens that they were randomized to for an additional 6 weeks of wear.
Outcome measures
| Measure |
Etafilcon A
n=12 Participants
Subjects that wore the etafilcon A lens in either the first or second period of the study.
|
Nelfilcon A
n=12 Participants
Subjects that wore the nelfilcon A lens in either the first or second period of the study.
|
|---|---|---|
|
Quantity of Cytokines and Albumin in Tear Fluid
IL-6
|
12.70 (pg/ml)
Standard Deviation 11.281
|
11.91 (pg/ml)
Standard Deviation 17.135
|
|
Quantity of Cytokines and Albumin in Tear Fluid
IL-8
|
480.99 (pg/ml)
Standard Deviation 353.994
|
481.08 (pg/ml)
Standard Deviation 346.982
|
|
Quantity of Cytokines and Albumin in Tear Fluid
TNF-a
|
1.20 (pg/ml)
Standard Deviation 1.111
|
0.49 (pg/ml)
Standard Deviation 0.242
|
|
Quantity of Cytokines and Albumin in Tear Fluid
IL-1B
|
2.83 (pg/ml)
Standard Deviation 1.595
|
4.99 (pg/ml)
Standard Deviation 6.297
|
|
Quantity of Cytokines and Albumin in Tear Fluid
IL-2
|
1.50 (pg/ml)
Standard Deviation 1.528
|
1.06 (pg/ml)
Standard Deviation 0.569
|
|
Quantity of Cytokines and Albumin in Tear Fluid
IL-10
|
0.90 (pg/ml)
Standard Deviation 1.002
|
0.55 (pg/ml)
Standard Deviation 0.341
|
|
Quantity of Cytokines and Albumin in Tear Fluid
IL-12
|
0.42 (pg/ml)
Standard Deviation 0.139
|
0.56 (pg/ml)
Standard Deviation 0.222
|
|
Quantity of Cytokines and Albumin in Tear Fluid
IL-13
|
17.78 (pg/ml)
Standard Deviation 17.396
|
14.10 (pg/ml)
Standard Deviation 8.998
|
PRIMARY outcome
Timeframe: 12 wks after baselinePopulation: All subjects that completed all study visits without a major protocol deviation. All 12 subjects completed the study, however in some subjects the concentration of cytokine levels were below detectable limits in the tear film sample and could not be analyzed.
Measured cytokines: IL-1β, IL-2, IL-6, IL-8, IL-10, IL-12, IL-13, and TNF-alpha. Measurement will be taken after the subject has worn the lenses for a full seven hours. During the 2nd period subjects continued wearing the current lens that they were randomized to for an additional 6 weeks of wear.
Outcome measures
| Measure |
Etafilcon A
n=12 Participants
Subjects that wore the etafilcon A lens in either the first or second period of the study.
|
Nelfilcon A
n=12 Participants
Subjects that wore the nelfilcon A lens in either the first or second period of the study.
|
|---|---|---|
|
Quantity of Cytokines and Albumin in Tear Fluid
TFN-a
|
0.57 (pg/ml)
Standard Deviation 0.411
|
0.85 (pg/ml)
Standard Deviation 0.772
|
|
Quantity of Cytokines and Albumin in Tear Fluid
IL-1B
|
5.18 (pg/ml)
Standard Deviation 6.079
|
8.14 (pg/ml)
Standard Deviation 10.250
|
|
Quantity of Cytokines and Albumin in Tear Fluid
IL-2
|
1.43 (pg/ml)
Standard Deviation 1.314
|
1.09 (pg/ml)
Standard Deviation 0.479
|
|
Quantity of Cytokines and Albumin in Tear Fluid
IL-6
|
10.18 (pg/ml)
Standard Deviation 6.155
|
21.33 (pg/ml)
Standard Deviation 26.329
|
|
Quantity of Cytokines and Albumin in Tear Fluid
IL-8
|
473.86 (pg/ml)
Standard Deviation 164.445
|
879.82 (pg/ml)
Standard Deviation 922.383
|
|
Quantity of Cytokines and Albumin in Tear Fluid
IL-10
|
0.85 (pg/ml)
Standard Deviation 1.060
|
1.17 (pg/ml)
Standard Deviation 0.618
|
|
Quantity of Cytokines and Albumin in Tear Fluid
IL-12
|
0.74 (pg/ml)
Standard Deviation 0.211
|
0.51 (pg/ml)
Standard Deviation 0.429
|
|
Quantity of Cytokines and Albumin in Tear Fluid
IL-13
|
14.56 (pg/ml)
Standard Deviation 5.053
|
29.91 (pg/ml)
Standard Deviation 8.963
|
Adverse Events
Etafilcon A
Nelfilcon A
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Etafilcon A
n=28 participants at risk
Subjects that wore the etafilcon A lens in either the first or second period of the study.
|
Nelfilcon A
n=28 participants at risk
Subjects that wore the nelfilcon A lens in either the first or second period of the study.
|
|---|---|---|
|
Infections and infestations
Common Cold
|
0.00%
0/28 • Approximately 81-87 days per subject.
|
7.1%
2/28 • Number of events 2 • Approximately 81-87 days per subject.
|
Additional Information
Chantal Coles-Brennan
Johnson & Johnson Vision Care Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60