Comparison of Tear Evaporation Rate With DAILIES TOTAL1 and Biotrue ONEday

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Tear Evaporation Rate With DAILIES TOTAL1 and Biotrue ONEday

Conditions
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Evaporative Dry Eye

Intervention / Treatment
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* Device: Nesofilcon A
* Device: Delefilcon A


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 17 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nesofilcon A/Delefilcon A<br>Nesofilcon A was worn in right eye and delefilcon A worn in the left eye. | Device: Nesofilcon A<br>* Hydrogel contact lens for daily wear<br>Device: Delefilcon A<br>* Silicone hydrogel contact lens for daily wear<br>|
| Experimental: Delefilcon A/Nesofilcon A<br>Delefilcon A was worn in right eye and Nesofilcon A worn in the left eye. | Device: Nesofilcon A<br>* Hydrogel contact lens for daily wear<br>Device: Delefilcon A<br>* Silicone hydrogel contact lens for daily wear<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear Evaporation Rate With Nesofilcon A | 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. | Baseline, 15 minutes post-contact lens, 6 hours post-contact lens | 
| Tear Evaporation Rate With Delefilcon A | 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. | Baseline, 15 minutes post-contact lens, 6 hours post-contact lens |