N/A
N=20
Comparison of Tear Evaporation Rate With DAILIES TOTAL1 and Biotrue ONEday
Evaporative Dry Eye
Bottom Line
View on ClinicalTrials.gov: NCT04037969 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Tear Evaporation Rate With Nesofilcon A — 0.81; 0.88; 0.92 % relative humidity per second
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nesofilcon A (Device); Delefilcon A (Device)
- Age
- Pediatric, Adult, Older Adult · 17+ yrs
- Sex
- All
- Sponsor
- University of Waterloo
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tear Evaporation Rate With Nesofilcon A |
0.81; 0.88; 0.92 | — |
| PRIMARY Tear Evaporation Rate With Delefilcon A |
0.74; 0.87; 0.95 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Is at least 17 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;
- Has worn soft contact lenses for a minimum of 6 months;
- Currently wears soft contact lenses for at least 4 days per week and 8 hours per day;
- Has an acceptable fit and comfort with both study contact lenses in the powers available;
- Has less than or equal to 1.00DS difference between eyes in their habitual contact lenses;
- Is willing to be awake for at least 2 hours before visit 2;
- Is willing to not wear eye makeup on the day of visit 2 and 3;
- Is willing to not use eye drops or artificial tears on the day of visits 1, 2, and 3;
- Has a wearable pair of spectacles.
Exclusion Criteria
- Is participating in any concurrent clinical or research study;
- Has any known active* ocular disease and/or infection;
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- Has known sensitivity to sodium fluorescein dye;
- Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
- Is aphakic;
- Has undergone refractive error surgery;
- Has a known sensitivity to petroleum jelly (Vaseline);
- Has epilepsy and/or a sensitivity to flashing lights;
- Wears toric contact lenses;
- Has any physical impairment that would interfere with holding the evaporimeter;
- Has taken part in another research study within the last 14 days.
Data sourced from ClinicalTrials.gov (NCT04037969). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.