Comparison of Tear Evaporation Rate With DAILIES TOTAL1 and Biotrue ONEday
- Conditions
- Evaporative Dry Eye
- Interventions
- Device: Nesofilcon ADevice: Delefilcon A
- Registration Number
- NCT04037969
- Lead Sponsor
- University of Waterloo
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nesofilcon A/Delefilcon A Delefilcon A Nesofilcon A was worn in right eye and delefilcon A worn in the left eye. Delefilcon A/Nesofilcon A Delefilcon A Delefilcon A was worn in right eye and Nesofilcon A worn in the left eye. Nesofilcon A/Delefilcon A Nesofilcon A Nesofilcon A was worn in right eye and delefilcon A worn in the left eye. Delefilcon A/Nesofilcon A Nesofilcon A Delefilcon A was worn in right eye and Nesofilcon A worn in the left eye.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Centre for Ocular Research & Education
🇨🇦Waterloo, Ontario, Canada