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The purpose of this pilot study is to compare the effect of DAILIES TOTAL1, a low water content silicone hydrogel lens, and Biotrue ONEday, a high water content hydrogel lens, on the rate of tear evaporation. The study will also serve to validate the novel, in-house developed evaporimeter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nesofilcon A/Delefilcon A | Experimental | Nesofilcon A was worn in right eye and delefilcon A worn in the left eye. |
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| Delefilcon A/Nesofilcon A | Experimental | Delefilcon A was worn in right eye and Nesofilcon A worn in the left eye. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nesofilcon A | Device | Hydrogel contact lens for daily wear |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tear Evaporation Rate With Nesofilcon A | Tear film evaporation rate (% relative humidity per second) was performed using a novel evaporimeter as a non-invasive measurement of tear film evaporation. The slope was calculated from the change in humidity between 7 to 17.5 seconds while the eye was open and between 10 to 17.5 seconds when the eye was closed. Data from the both eyes were analyzed. | Baseline, 15 minutes post-contact lens, 6 hours post-contact lens |
| Tear Evaporation Rate With Delefilcon A | Tear film evaporation rate (% relative humidity per second) was performed using a novel evaporimeter as a non-invasive measurement of tear film evaporation. The slope was calculated from the change in humidity between 7 to 17.5 seconds while the eye was open and between 10 to 17.5 seconds when the eye was closed. Data from the both eyes were analyzed. | Baseline, 15 minutes post-contact lens, 6 hours post-contact lens |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Ocular Research & Education | Waterloo | Ontario | N2L 3G1 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nesofilcon A/Delefilcon A | Nesofilcon A randomly assigned to one eye with delefilcon A in the fellow eye. Nesofilcon A: Hydrogel contact lens for daily wear |
| FG001 | Delefilcon A/Nesofilcon A | Delefilcon A randomly assigned to one eye with nesofilcon A in the fellow eye. Delefilcon A: Silicone hydrogel contact lens for daily wear |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nesofilcon A/Delefilcon A | Nesofilcon A randomly assigned to one eye with delefilcon A in the fellow eye. Nesofilcon A: Hydrogel contact lens for daily wear |
| BG001 | Delefilcon A/Nesofilcon A |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Tear Evaporation Rate With Nesofilcon A | Tear film evaporation rate (% relative humidity per second) was performed using a novel evaporimeter as a non-invasive measurement of tear film evaporation. The slope was calculated from the change in humidity between 7 to 17.5 seconds while the eye was open and between 10 to 17.5 seconds when the eye was closed. Data from the both eyes were analyzed. | Posted | Mean | Standard Deviation | % relative humidity per second | Baseline, 15 minutes post-contact lens, 6 hours post-contact lens |
|
One day
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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 | Nesofilcon A/Delefilcon A | Nesofilcon A randomly assigned to one eye with delefilcon A in the fellow eye. Nesofilcon A: Hydrogel contact lens for daily wear |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jill Woods | Centre for Ocular Research and Education | 5198884567 | 36743 | jwoods@uwaterloo.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 24, 2019 | Mar 11, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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Participants and investigators are masked as to which lens is assigned to each eye.
| Delefilcon A | Device | Silicone hydrogel contact lens for daily wear |
|
Delefilcon A randomly assigned to one eye with nesofilcon A in the fellow eye.
Delefilcon A: Silicone hydrogel contact lens for daily wear
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Tear Evaporation Rate With Delefilcon A | Tear film evaporation rate (% relative humidity per second) was performed using a novel evaporimeter as a non-invasive measurement of tear film evaporation. The slope was calculated from the change in humidity between 7 to 17.5 seconds while the eye was open and between 10 to 17.5 seconds when the eye was closed. Data from the both eyes were analyzed. | Posted | Mean | Standard Deviation | % relative humidity per second | Baseline, 15 minutes post-contact lens, 6 hours post-contact lens |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Delefilcon A/Nesofilcon A | Delefilcon A randomly assigned to one eye with nesofilcon A in the fellow eye. Delefilcon A: Silicone hydrogel contact lens for daily wear | 0 | 10 | 0 | 10 | 0 | 10 |
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| Title | Measurements |
|---|---|
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