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Completed

NCT Number: NCT04037969

Comparison of Tear Evaporation Rate With DAILIES TOTAL1 and Biotrue ONEday

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.

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Key information

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Ocular Research & Education

Waterloo, Ontario, N2L 3G1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nesofilcon A

Device

Hydrogel contact lens for daily wear

delefilcon A

Device

Silicone hydrogel contact lens for daily wear

Primary outcomes

  1. Tear Evaporation Rate With Nesofilcon A

    Time frame: 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.

  2. Tear Evaporation Rate With Delefilcon A

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Waterloo

Other

Registry information

Acronym: MALTESE

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 30, 2019
Registry last updated
Apr 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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