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The objective of the study is to compare the rate of tear evaporation, measured with a novel evaporimeter, before and for one hour after an eye drop containing nano-sized oil droplets has been instilled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Dry Eye | Experimental | Instill eye drop and perform followup assessments on people with a Ocular Surface Disease Index score <13 and a non-invasive Keratograph break-up time of >/= 10 seconds in the worst eye |
|
| Dry Eye | Experimental | Instill eye drop and perform followup assessments on people with an Ocular Surface Disease Index score >/= 13 and a non-invasive Keratograph break-up time \ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Systane Complete | Drug | Systane Complete will be instilled and rate of evaporation assessed before and after. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tear Evaporation Rate | 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 right eye was analyzed. | Baseline (Prior to instillation); 10, 30 and 60 minutes post instillation of eye drop |
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Inclusion Criteria:
Is at least 18 years of age and has full legal capacity to volunteer;
Has read and signed an information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Is willing to be awake for at least 2 hours before visit 2;
Is willing not to wear eye makeup on the day of visit 2;
Is willing not to use eye drops or artificial tears on the days of visits 1 or 2;
Group specific criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lyndon Jones, PhD, FCOptom | Centre for Ocular Research & Education | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Ocular Research & Education | Waterloo | Ontario | N2L 3G1 | Canada |
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Participants were recruited from a single study center located in Canada.
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-Dry Eye | Tear evaporation was measured prior to and after a single 15 µl instillation of Systane Complete was instilled in people with an Ocular Surface Disease Index score <13 and a non-invasive Keratograph break-up time >/= 10 seconds in the worst eye. |
| FG001 | Dry Eye | Tear evaporation was measured prior to and after a single 15 µl instillation of Systane Complete in people with an Ocular Surface Disease Index score >/= 13 and a non-invasive Keratograph break-up time \ |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-Dry Eye | Tear evaporation was measured prior to and after Systane Complete was instilled. |
| BG001 | Dry Eye | Tear evaporation was measured prior to and after Systane Complete was instilled. |
| 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 | Tear Evaporation Rate | 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 right eye was analyzed. | The analysis population includes all participants that were exposed to Systane Complete, and excludes the one dry eye subject that was lost to follow-up. | Posted | Mean | Standard Deviation | % relative humidity per second | Baseline (Prior to instillation); 10, 30 and 60 minutes post instillation of eye drop |
|
Adverse events were collected from the time of consent for the duration of the study (up to 2 weeks). Adverse events are reported as pre-treatment or post-treatment.
An adverse event was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, whether or not related to the medical device.
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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 | Non-Dry Eye | Tear evaporation was measured prior to and after Systane Complete was instilled in a group of people without dry eye that had an Ocular Surface Disease Index score <13 and a non-invasive Keratograph break-up time >/= 10 seconds in the worst eye. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | Infections and infestations | Systematic Assessment |
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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 31, 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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| BG002 | Total | Total of all reporting groups |
| 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 |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Dry Eye |
Tear evaporation was measured prior to and after Systane Complete was instilled in people with dry eye. |
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|
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| 1 |
| 10 |
| 0 |
| 10 |
| 1 |
| 10 |
| EG001 | Dry Eye | Tear evaporation was measured prior to and after Systane Complete was instilled in a group of people with dry eye that had an Ocular Surface Disease Index score >/=13 and a non-invasive Keratograph break-up time \ | 2 | 11 | 0 | 11 | 2 | 11 |
| Steroid injection | Surgical and medical procedures | Systematic Assessment |
|
| Common cold | Infections and infestations | Systematic Assessment |
|
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