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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| etafilcon A | Experimental | Worn in a daily disposable modality |
|
| nelfilcon A | Active Comparator | Worn in a daily disposable modality |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etafilcon A | Device | etafilcon A soft contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Protein and Total Lysosome Deposits | Measurement will be taken after the subject has worn the lenses for a full seven hours | 2 wks after baseline |
| Total Protein and Total Lysosome Deposits | Measurement will be taken after the subject has worn the lenses for a full seven hours | 6 wks after baseline |
| Total Protein and Lysosome Deposits | Measurement will be taken after the subject has worn the lenses for a full seven hours | 12 wks after baseline |
| Quantity of Cytokines and Albumin in Tear Fluid | 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. | 2 wks after baseline |
| Quantity of Cytokines and Albumin in Tear Fluid | 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. | 6 wks after baseline |
| Quantity of Cytokines and Albumin in Tear Fluid | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Waterloo | Waterloo | Ontario | N2L 3G1 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Etafilcon a /Nelfilcon A | Subjects that were randomized to receive the etafilcon A lens first, and then to receive the nelfilcon A lens second. |
| FG001 | Nelfilcon A / Etafilcon A | Subjects that were randomized to receive the nelfilcon A lens first, and then to receive the etafilcon A lens second. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 |
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All subjects dispensed at least one study lens during the duration of the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Dispensed Subjects | All subjects that were dispensed a study lens. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Protein and Total Lysosome Deposits | Measurement will be taken after the subject has worn the lenses for a full seven hours | All subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | (ug/lens) | 2 wks after baseline |
|
Approximately 81-87 days per subject.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Etafilcon A | Subjects that wore the etafilcon A lens in either the first or second period of the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Common Cold | Infections and infestations | Not Study Related |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chantal Coles-Brennan | Johnson & Johnson Vision Care Inc. | 904-443-3449 | CColesb@ITS.JNJ.com |
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| nelfilcon A | Device | nelfilcon A |
|
|
| 12 wks after baseline |
| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Total Protein and Total Lysosome Deposits | Measurement will be taken after the subject has worn the lenses for a full seven hours | 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. | Posted | Mean | Standard Deviation | (ug/lens) | 6 wks after baseline |
|
|
|
| Primary | Total Protein and Lysosome Deposits | Measurement will be taken after the subject has worn the lenses for a full seven hours | 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. | Posted | Mean | Standard Deviation | (ug/lens) | 12 wks after baseline |
|
|
|
| Primary | Quantity of Cytokines and Albumin in Tear Fluid | 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. | 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. | Posted | Mean | Standard Deviation | (pg/ml) | 2 wks after baseline |
|
|
|
| Primary | Quantity of Cytokines and Albumin in Tear Fluid | 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. | 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. | Posted | Mean | Standard Deviation | (pg/ml) | 6 wks after baseline |
|
|
|
| Primary | Quantity of Cytokines and Albumin in Tear Fluid | 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. | 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. | Posted | Mean | Standard Deviation | (pg/ml) | 12 wks after baseline |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Nelfilcon A | Subjects that wore the nelfilcon A lens in either the first or second period of the study. | 0 | 28 | 2 | 28 |
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| Total Proteins |
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| Total Proteins |
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| IL-1B |
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| IL-2 |
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| IL-6 |
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| IL-8 |
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| IL-10 |
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| IL-12 |
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| IL-13 |
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| IL-1B |
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| IL-2 |
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| IL-6 |
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| IL-8 |
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| IL-10 |
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| IL-12 |
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| IL-13 |
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| IL-1B |
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| IL-2 |
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| IL-6 |
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| IL-8 |
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| IL-10 |
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| IL-12 |
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| IL-13 |
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