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NCT02365298

Clinical and Laboratory Study of Lysozyme Deposition on Daily Disposable Contact Lenses

Completed NA Results posted Last updated 19 June 2018
What this trial tests

NA trial testing etafilcon A in Visual Acuity in 28 participants. Completed in 1 June 2015.

Timeline
1 January 2015
Primary endpoint
1 June 2015
1 June 2015

Quick facts

Lead sponsorJohnson & Johnson Vision Care, Inc.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingdouble
Primary purposebasic science
Enrollment28
Start date1 January 2015
Primary completion1 June 2015
Estimated completion1 June 2015
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

Johnson & Johnson Vision Care, Inc. — full company profile →

Who can join

Adults 18 to 40, any sex, with Visual Acuity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Total Protein and Total Lysosome Deposits Primary · 2 wks after baseline

Measurement will be taken after the subject has worn the lenses for a full seven hours

Total Lysozyme
GroupValue95% CI
Etafilcon A294.58± 113.855
Nelfilcon A1.68± 0.975
Active Lysozyme
GroupValue95% CI
Etafilcon A244.00± 87.325
Nelfilcon A0.93± 0.650
Total Proteins
GroupValue95% CI
Etafilcon A482.06± 139.196
Nelfilcon A6.46± 3.953
Total Protein and Total Lysosome Deposits Primary · 6 wks after baseline

Measurement will be taken after the subject has worn the lenses for a full seven hours

Total Lysozyme
GroupValue95% CI
Etafilcon A349.00± 58.845
Nelfilcon A2.26± 1.460
Active Lysozyme
GroupValue95% CI
Etafilcon A263.92± 38.562
Nelfilcon A1.13± 0.538
Total Proteins
GroupValue95% CI
Etafilcon A473.58± 131.432
Nelfilcon A7.46± 4.151
Total Protein and Lysosome Deposits Primary · 12 wks after baseline

Measurement will be taken after the subject has worn the lenses for a full seven hours

Total Lysozyme
GroupValue95% CI
Etafilcon A289.17± 78.838
Nelfilcon A1.58± 0.851
Active Lysozymes
GroupValue95% CI
Etafilcon A242.75± 57.974
Nelfilcon A1.01± 0.567
Total Proteins
GroupValue95% CI
Etafilcon A394.42± 122.302
Nelfilcon A5.87± 3.181
Quantity of Cytokines and Albumin in Tear Fluid Primary · 2 wks after baseline

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.

TFN-a
GroupValue95% CI
Etafilcon A1.20± 0.528
Nelfilcon A1.17± 1.095
IL-1B
GroupValue95% CI
Etafilcon A1.70± 1.810
Nelfilcon A2.32± 3.023
IL-2
GroupValue95% CI
Etafilcon A1.19± 0.841
Nelfilcon A1.49± 1.770
IL-6
GroupValue95% CI
Etafilcon A12.32± 11.756
Nelfilcon A15.03± 18.835
IL-8
GroupValue95% CI
Etafilcon A466.32± 291.109
Nelfilcon A472.91± 273.444
IL-10
GroupValue95% CI
Etafilcon A2.02± 1.879
Nelfilcon A1.64± 1.389
IL-12
GroupValue95% CI
Etafilcon A2.72± 5.218
Nelfilcon A2.25± 2.685
IL-13
GroupValue95% CI
Etafilcon A29.62± 19.510
Nelfilcon A27.23± 23.651
Quantity of Cytokines and Albumin in Tear Fluid Primary · 6 wks after baseline

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.

TNF-a
GroupValue95% CI
Etafilcon A1.20± 1.111
Nelfilcon A0.49± 0.242
IL-1B
GroupValue95% CI
Etafilcon A2.83± 1.595
Nelfilcon A4.99± 6.297
IL-2
GroupValue95% CI
Etafilcon A1.50± 1.528
Nelfilcon A1.06± 0.569
IL-6
GroupValue95% CI
Etafilcon A12.70± 11.281
Nelfilcon A11.91± 17.135
IL-8
GroupValue95% CI
Etafilcon A480.99± 353.994
Nelfilcon A481.08± 346.982
IL-10
GroupValue95% CI
Etafilcon A0.90± 1.002
Nelfilcon A0.55± 0.341
IL-12
GroupValue95% CI
Etafilcon A0.42± 0.139
Nelfilcon A0.56± 0.222
IL-13
GroupValue95% CI
Etafilcon A17.78± 17.396
Nelfilcon A14.10± 8.998
Quantity of Cytokines and Albumin in Tear Fluid Primary · 12 wks after baseline

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.

TFN-a
GroupValue95% CI
Etafilcon A0.57± 0.411
Nelfilcon A0.85± 0.772
IL-1B
GroupValue95% CI
Etafilcon A5.18± 6.079
Nelfilcon A8.14± 10.250
IL-2
GroupValue95% CI
Etafilcon A1.43± 1.314
Nelfilcon A1.09± 0.479
IL-6
GroupValue95% CI
Etafilcon A10.18± 6.155
Nelfilcon A21.33± 26.329
IL-8
GroupValue95% CI
Etafilcon A473.86± 164.445
Nelfilcon A879.82± 922.383
IL-10
GroupValue95% CI
Etafilcon A0.85± 1.060
Nelfilcon A1.17± 0.618
IL-12
GroupValue95% CI
Etafilcon A0.74± 0.211
Nelfilcon A0.51± 0.429
IL-13
GroupValue95% CI
Etafilcon A14.56± 5.053
Nelfilcon A29.91± 8.963

Adverse events — posted to ClinicalTrials.gov

Time frame: Approximately 81-87 days per subject.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Etafilcon A
Serious: 0/28 (0%)
Deaths: —
Nelfilcon A
Serious: 0/28 (0%)
Deaths: —
Other adverse events (1 terms — click to expand)

ReactionSystemEtafilcon ANelfilcon A
Common ColdInfections and infestations——

Data from ClinicalTrials.gov NCT02365298 adverse events section.

Sponsor's own description

In vitro studies show that some hydrogel materials uptake more lysozyme than other hydrogel materials and that this protein remains largely active and promotes reduced cytokine response in an in vitro culture of human corneal epithelial cells. This study investigates whether these data transfer to the in vivo situation.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of etafilcon A

Trials testing the same drug.

Other recruiting trials for Visual Acuity

Currently open trials in the same condition.

Other Johnson & Johnson Vision Care, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02365298.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing