Evaporative Dry Eye
Conditions
Brief summary
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.
Interventions
DRUGSystane Complete
Systane Complete will be instilled and rate of evaporation assessed before and after.
Sponsors
University of Waterloo
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Is at least 18 years of age and has full legal capacity to volunteer; 2. Has read and signed an information consent letter; 3. Is willing and able to follow instructions and maintain the appointment schedule; 4. Is willing to be awake for at least 2 hours before visit 2; 5. Is willing not to wear eye makeup on the day of visit 2; 6. Is willing not to use eye drops or artificial tears on the days of visits 1 or 2; 7. Group specific criteria: 1. Dry eye participant group: Symptoms: OSDI ≥ 13 and Signs: NIKBUT ≤ 5 s in the worst eye 2. Non-dry eye participant group: Symptoms: OSDI \< 13 and Signs: NIKBUT ≥ 10 s in the worst eye
Exclusion criteria
1. Is participating in any concurrent clinical or research study; 2. Has any known active\* ocular disease and/or infection; 3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable; 4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; 5. Has known sensitivity to sodium fluorescein dye; 6. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit); 7. Is aphakic; 8. Has undergone refractive error surgery; 9. Has undergone ocular surgery in the last 6 months; 10. Has punctal plugs; 11. Has a known sensitivity to Systane eye drops (including Systane Balance, Systane Complete, Systane Gel Drops, Systane Ultra, etc.) 12. Has a known sensitivity to petroleum jelly (Vaseline); 13. Has epilepsy and/or sensitivity to flashing lights; 14. Has worn contact lenses within the past month or is planning to wear contact lenses during the study; 15. Has any physical impairment that would interfere with holding the evaporimeter; 16. Has taken part in another clinical research study involving ocular drops or treatments within the last 14 days; \* For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tear Evaporation Rate | Baseline (Prior to instillation); 10, 30 and 60 minutes post instillation of eye drop | 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. |
Countries
Canada
Participant flow
Recruitment details
Participants were recruited from a single study center located in Canada.
Participants by arm
| Arm | Count |
|---|---|
| Non-Dry Eye Tear evaporation was measured prior to and after Systane Complete was instilled. | 10 |
| Dry Eye Tear evaporation was measured prior to and after Systane Complete was instilled. | 11 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Dry Eye | Total | Non-Dry Eye |
|---|---|---|---|
| Age, Continuous | 45.4 years STANDARD_DEVIATION 22.7 | 39.3 years STANDARD_DEVIATION 19.4 | 32.6 years STANDARD_DEVIATION 12.8 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Canada | 11 participants | 21 participants | 10 participants |
| Sex: Female, Male Female | 10 Participants | 17 Participants | 7 Participants |
| Sex: Female, Male Male | 1 Participants | 4 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 10 | 2 / 11 |
| other Total, other adverse events | 1 / 10 | 2 / 11 |
| serious Total, serious adverse events | 0 / 10 | 0 / 11 |
Outcome results
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.
Time frame: Baseline (Prior to instillation); 10, 30 and 60 minutes post instillation of eye drop
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Dry Eye | Tear Evaporation Rate | Baseline | 1.15 % relative humidity per second | Standard Deviation 0.19 |
| Non-Dry Eye | Tear Evaporation Rate | 10 minutes post-drop | 1.26 % relative humidity per second | Standard Deviation 0.31 |
| Non-Dry Eye | Tear Evaporation Rate | 30 minutes post-drop | 1.01 % relative humidity per second | Standard Deviation 0.24 |
| Non-Dry Eye | Tear Evaporation Rate | 60 minutes post-drop | 1.07 % relative humidity per second | Standard Deviation 0.31 |
| Dry Eye | Tear Evaporation Rate | 60 minutes post-drop | 1.27 % relative humidity per second | Standard Deviation 0.27 |
| Dry Eye | Tear Evaporation Rate | 30 minutes post-drop | 1.18 % relative humidity per second | Standard Deviation 0.27 |
| Dry Eye | Tear Evaporation Rate | Baseline | 1.38 % relative humidity per second | Standard Deviation 0.22 |
| Dry Eye | Tear Evaporation Rate | 10 minutes post-drop | 1.32 % relative humidity per second | Standard Deviation 0.25 |
p-value: 0.002ANOVA
Comparison: Comparison of the baseline tear evaporation rate of the non-dry eye and dry eye group.p-value: 0.022t-test, 2 sided