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Completed

NCT Number: NCT04091581

Comparison of Tear Evaporation Rate With Systane Complete in Dry Eye and Non-Dry Eye

The objective of the study is to compare the rate of tear evaporation, measured with a novel evaporimeter, before and for one hour after an eye drop containing nano-sized oil droplets has been instilled.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

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 18 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;
  • Is willing to be awake for at least 2 hours before visit 2;
  • Is willing not to wear eye makeup on the day of visit 2;
  • Is willing not to use eye drops or artificial tears on the days of visits 1 or 2;
  • Group specific criteria:
  • Dry eye participant group: Symptoms: OSDI ≥ 13 and Signs: NIKBUT ≤ 5 s in the worst eye
  • Non-dry eye participant group: Symptoms: OSDI < 13 and Signs: NIKBUT ≥ 10 s in the worst eye

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 undergone ocular surgery in the last 6 months;
  • Has punctal plugs;
  • Has a known sensitivity to Systane eye drops (including Systane Balance, Systane Complete, Systane Gel Drops, Systane Ultra, etc.)
  • Has a known sensitivity to petroleum jelly (Vaseline);
  • Has epilepsy and/or sensitivity to flashing lights;
  • Has worn contact lenses within the past month or is planning to wear contact lenses during the study;
  • Has any physical impairment that would interfere with holding the evaporimeter;
  • Has taken part in another clinical research study involving ocular drops or treatments within the last 14 days; * For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

Treatment and study plan

Systane COMPLETE

Drug

Systane Complete will be instilled and rate of evaporation assessed before and after.

Primary outcomes

  1. Tear Evaporation Rate

    Time frame: Baseline (Prior to instillation); 10, 30 and 60 minutes post instillation of eye drop

    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 right eye was analyzed.

Sponsors and collaborators

Lead sponsor

University of Waterloo

Other

Registry information

Acronym: BULLDOG

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 17, 2019
Registry last updated
Jun 22, 2022

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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