Trial Outcomes & Findings for Comparison of Tear Evaporation Rate With Systane Complete in Dry Eye and Non-Dry Eye (NCT NCT04091581)
NCT ID: NCT04091581
Last Updated: 2022-06-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
21 participants
Primary outcome timeframe
Baseline (Prior to instillation); 10, 30 and 60 minutes post instillation of eye drop
Results posted on
2022-06-22
Participant Flow
Participants were recruited from a single study center located in Canada.
Participant milestones
| Measure |
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.
|
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 \</= 5 seconds in the worst eye.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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 \</= 5 seconds in the worst eye.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Non-Dry Eye
n=10 Participants
Tear evaporation was measured prior to and after Systane Complete was instilled.
|
Dry Eye
n=11 Participants
Tear evaporation was measured prior to and after Systane Complete was instilled.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.6 years
STANDARD_DEVIATION 12.8 • n=10 Participants
|
45.4 years
STANDARD_DEVIATION 22.7 • n=11 Participants
|
39.3 years
STANDARD_DEVIATION 19.4 • n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=10 Participants
|
10 Participants
n=11 Participants
|
17 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=10 Participants
|
1 Participants
n=11 Participants
|
4 Participants
n=21 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
10 participants
n=10 Participants
|
11 participants
n=11 Participants
|
21 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline (Prior to instillation); 10, 30 and 60 minutes post instillation of eye dropPopulation: 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.
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.
Outcome measures
| Measure |
Non-Dry Eye
n=10 Participants
Tear evaporation was measured prior to and after Systane Complete was instilled in people without dry eye.
|
Dry Eye
n=10 Participants
Tear evaporation was measured prior to and after Systane Complete was instilled in people with dry eye.
|
|---|---|---|
|
Tear Evaporation Rate
Baseline
|
1.15 % relative humidity per second
Standard Deviation 0.19
|
1.38 % relative humidity per second
Standard Deviation 0.22
|
|
Tear Evaporation Rate
10 minutes post-drop
|
1.26 % relative humidity per second
Standard Deviation 0.31
|
1.32 % relative humidity per second
Standard Deviation 0.25
|
|
Tear Evaporation Rate
30 minutes post-drop
|
1.01 % relative humidity per second
Standard Deviation 0.24
|
1.18 % relative humidity per second
Standard Deviation 0.27
|
|
Tear Evaporation Rate
60 minutes post-drop
|
1.07 % relative humidity per second
Standard Deviation 0.31
|
1.27 % relative humidity per second
Standard Deviation 0.27
|
Adverse Events
Non-Dry Eye
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Dry Eye
Serious events: 0 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Non-Dry Eye
n=10 participants at risk
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.
|
Dry Eye
n=11 participants at risk
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 \</= 5 seconds in the worst eye.
|
|---|---|---|
|
Infections and infestations
Fever
|
0.00%
0/10 • 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.
|
9.1%
1/11 • Number of events 1 • 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.
|
|
Surgical and medical procedures
Steroid injection
|
0.00%
0/10 • 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.
|
9.1%
1/11 • Number of events 1 • 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.
|
|
Infections and infestations
Common cold
|
10.0%
1/10 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place