Evaporative Dry Eye
Conditions
Brief summary
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.
Interventions
DEVICENesofilcon A
Hydrogel contact lens for daily wear
DEVICEDelefilcon A
Silicone hydrogel contact lens for daily wear
Sponsors
University of Waterloo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Masking description
Participants and investigators are masked as to which lens is assigned to each eye.
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Is at least 17 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. Has worn soft contact lenses for a minimum of 6 months; 5. Currently wears soft contact lenses for at least 4 days per week and 8 hours per day; 6. Has an acceptable fit and comfort with both study contact lenses in the powers available; 7. Has less than or equal to 1.00DS difference between eyes in their habitual contact lenses; 8. Is willing to be awake for at least 2 hours before visit 2; 9. Is willing to not wear eye makeup on the day of visit 2 and 3; 10. Is willing to not use eye drops or artificial tears on the day of visits 1, 2, and 3; 11. Has a wearable pair of spectacles.
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 a known sensitivity to petroleum jelly (Vaseline); 10. Has epilepsy and/or a sensitivity to flashing lights; 11. Wears toric contact lenses; 12. Has any physical impairment that would interfere with holding the evaporimeter; 13. Has taken part in another research study within the last 14 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tear Evaporation Rate With Nesofilcon A | Baseline, 15 minutes post-contact lens, 6 hours post-contact lens | 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. |
| Tear Evaporation Rate With Delefilcon A | Baseline, 15 minutes post-contact lens, 6 hours post-contact lens | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 10 |
| 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 | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Delefilcon A/Nesofilcon A | Total | Nesofilcon A/Delefilcon A |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 19 Participants | 9 Participants |
| Age, Continuous | 25.1 years STANDARD_DEVIATION 9.6 | 28.2 years STANDARD_DEVIATION 13.9 | 31.2 years STANDARD_DEVIATION 17.1 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Canada | 10 participants | 20 participants | 10 participants |
| Sex: Female, Male Female | 10 Participants | 19 Participants | 9 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
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.
Time frame: Baseline, 15 minutes post-contact lens, 6 hours post-contact lens
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Full Group | Tear Evaporation Rate With Delefilcon A | Baseline | 0.74 % relative humidity per second | Standard Deviation 0.21 |
| Full Group | Tear Evaporation Rate With Delefilcon A | 15 minutes post-contact lenses | 0.87 % relative humidity per second | Standard Deviation 0.24 |
| Full Group | Tear Evaporation Rate With Delefilcon A | 6 hours post-contact lenses | 0.95 % relative humidity per second | Standard Deviation 0.3 |
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.
Time frame: Baseline, 15 minutes post-contact lens, 6 hours post-contact lens
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Full Group | Tear Evaporation Rate With Nesofilcon A | Baseline | 0.81 % relative humidity per second | Standard Deviation 0.3 |
| Full Group | Tear Evaporation Rate With Nesofilcon A | 15 minutes post-contact lenses | 0.88 % relative humidity per second | Standard Deviation 0.32 |
| Full Group | Tear Evaporation Rate With Nesofilcon A | 6 hours post-contact lenses | 0.92 % relative humidity per second | Standard Deviation 0.38 |