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Comparison of Tear Evaporation Rate With DAILIES TOTAL1 and Biotrue ONEday

Not Applicable
Completed
Conditions
Evaporative Dry Eye
Interventions
Device: Nesofilcon A
Device: 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
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Nesofilcon A/Delefilcon ADelefilcon ANesofilcon A was worn in right eye and delefilcon A worn in the left eye.
Delefilcon A/Nesofilcon ADelefilcon ADelefilcon A was worn in right eye and Nesofilcon A worn in the left eye.
Nesofilcon A/Delefilcon ANesofilcon ANesofilcon A was worn in right eye and delefilcon A worn in the left eye.
Delefilcon A/Nesofilcon ANesofilcon ADelefilcon A was worn in right eye and Nesofilcon A worn in the left eye.
Primary Outcome Measures
NameTimeMethod
Tear Evaporation Rate With Nesofilcon ABaseline, 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 ABaseline, 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
NameTimeMethod

Trial Locations

Locations (1)

Centre for Ocular Research & Education

🇨🇦

Waterloo, Ontario, Canada

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