A Phase 4 interventional study of Systane Complete in Evaporative Dry Eye, sponsored by University of Waterloo. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-22.
Sponsored by University of Waterloo · Phase 4, Interventional, and Diagnostic
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.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's enrollment of 21 is below the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →University of Waterloo is the lead sponsor of 90 studies on the registry; 8 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 9 (75%) have results posted.
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Group specific criteria:
Exclusion Criteria:
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
Drug: Systane Complete
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 \</= 5 seconds in the worst eye
Drug: Systane Complete
Systane Complete will be instilled and rate of evaporation assessed before and after.
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.
Time frame: Baseline (Prior to instillation); 10, 30 and 60 minutes post instillation of eye drop
Participants were recruited from a single study center located in Canada.
| Milestone | Non-Dry Eye | Dry Eye |
|---|---|---|
| Started | 10 | 11 |
| Completed | 10 | 10 |
| Not completed | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
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.
| % relative humidity per second | Non-Dry Eye | Dry Eye |
|---|---|---|
| Baseline | 1.15 ± 0.19 | 1.38 ± 0.22 |
| 10 minutes post-drop | 1.26 ± 0.31 | 1.32 ± 0.25 |
| 30 minutes post-drop | 1.01 ± 0.24 | 1.18 ± 0.27 |
| 60 minutes post-drop | 1.07 ± 0.31 | 1.27 ± 0.27 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Non-Dry Eye | 1/10 (10%) | 0/10 (0%) | 1/10 (10%) |
| Dry Eye | 2/11 (18.2%) | 0/11 (0%) | 2/11 (18.2%) |
| Event | Non-Dry Eye | Dry Eye |
|---|---|---|
| Common coldInfections and infestations | 1/10 | 0/11 |
| FeverInfections and infestations | 0/10 | 1/11 |
| Steroid injectionSurgical and medical procedures | 0/10 | 1/11 |
| Age, Continuous(years) | Non-Dry Eye | Dry Eye | Total |
|---|---|---|---|
| Mean | 32.6 ± 12.8 | 45.4 ± 22.7 | 39.3 ± 19.4 |
| Sex: Female, Male(Participants) | Non-Dry Eye | Dry Eye | Total |
|---|---|---|---|
| Female | 7 | 10 | 17 |
| Male | 3 | 1 | 4 |
| Race and Ethnicity Not Collected(Participants) | Non-Dry Eye | Dry Eye | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Non-Dry Eye | Dry Eye | Total |
|---|---|---|---|
| Canada | 10 | 11 | 21 |
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University of Waterloo