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

Phase 4

Completed

Conditions: Evaporative Dry Eye

Interventions: Drug: Systane Complete

Registration Number: NCT04091581

Lead Sponsor: University of Waterloo

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 21

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:
1. Dry eye participant group: Symptoms: OSDI ≥ 13 and Signs: NIKBUT ≤ 5 s in the worst eye
2. 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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dry Eye	Systane Complete	Instill eye drop and perform followup assessments on people with an Ocular Surface Disease Index score \>/= 13 and a non-invasive Keratograph break-up time \</= 5 seconds in the worst eye
Non-Dry Eye	Systane Complete	Instill eye drop and perform followup assessments on people with a Ocular Surface Disease Index score \<13 and a non-invasive Keratograph break-up time of \>/= 10 seconds in the worst eye

Primary Outcome Measures

Name	Time	Method
Tear Evaporation Rate	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.

Secondary Outcome Measures