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

Study Overview
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Brief Summary
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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.

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

Conditions
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Evaporative Dry Eye

Intervention / Treatment
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* Drug: Systane Complete


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-Dry Eye<br>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 | Drug: Systane Complete<br>* Systane Complete will be instilled and rate of evaporation assessed before and after.<br>|
| Experimental: Dry Eye<br>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 | Drug: Systane Complete<br>* Systane Complete will be instilled and rate of evaporation assessed before and after.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear Evaporation Rate | 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. | Baseline (Prior to instillation); 10, 30 and 60 minutes post instillation of eye drop |