DAILIES TOTAL1® - Comparative Assessment of Tear Film Evaporation

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the tear film evaporation of symptomatic soft contact lens wearers in the absence of contact lens wear and after at least 8 hours of contact lens wear.

Detailed Description
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This study consists of 5 visits (1 screening, 4 assessment) with a maximum of 6 days between assessment visits and at least 24 hours of no lens wear the day prior to the visit. Each subject will be randomized to a crossover sequence of 4 periods. Different study lenses will be worn during 3 of the periods, for at least 8 hours each, and the remaining period will have no lens wear.

Official Title
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Pilot Study on the Effect of Daily Disposable Silicone Hydrogel Contact Lenses on Tear Film Lipids

Conditions
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Refractive Error

Intervention / Treatment
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* Device: Delefilcon A contact lenses
* Device: Narafilcon A contact lenses
* Device: Somofilcon A contact lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign an informed consent document; Adapted, current soft contact lens wearer; Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Questionnaire; Can be successfully fitted with study lenses; Willing to wear lenses for a minimum of 8 hours prior to each study visit; Willing to discontinue artificial tears and rewetting drops usage on the days of study visits; Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear; Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator; Monocular (only 1 eye with functional vision) or fit with only one lens; History of herpetic keratitis, ocular surgery, or irregular cornea; Known pregnancy and lactation; Other protocol-specified exclusion criteria may apply.

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sequence 1<br>Delefilcon A, then narafilcon A, then somofilcon A, then no lens wear. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period. | Device: Delefilcon A contact lenses<br>* Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions<br>* Other names: DAILIES TOTAL1®;Device: Narafilcon A contact lenses<br>* Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions<br>* Other names: 1-DAY ACUVUE® TruEye®;Device: Somofilcon A contact lenses<br>* Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions<br>* Other names: clariti® 1 day;|
| Other: Sequence 2<br>Narafilcon A, then no lens wear, then delefilcon A, then somofilcon A. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period. | Device: Delefilcon A contact lenses<br>* Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions<br>* Other names: DAILIES TOTAL1®;Device: Narafilcon A contact lenses<br>* Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions<br>* Other names: 1-DAY ACUVUE® TruEye®;Device: Somofilcon A contact lenses<br>* Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions<br>* Other names: clariti® 1 day;|
| Other: Sequence 3<br>Somofilcon A, then delefilcon A, then no lens wear, then narafilcon A. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period. | Device: Delefilcon A contact lenses<br>* Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions<br>* Other names: DAILIES TOTAL1®;Device: Narafilcon A contact lenses<br>* Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions<br>* Other names: 1-DAY ACUVUE® TruEye®;Device: Somofilcon A contact lenses<br>* Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions<br>* Other names: clariti® 1 day;|
| Other: Sequence 4<br>No lens wear, then somofilcon A, then narafilcon A, then delefilcon A. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period. | Device: Delefilcon A contact lenses<br>* Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions<br>* Other names: DAILIES TOTAL1®;Device: Narafilcon A contact lenses<br>* Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions<br>* Other names: 1-DAY ACUVUE® TruEye®;Device: Somofilcon A contact lenses<br>* Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions<br>* Other names: clariti® 1 day;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear Film Evaporation Rate | Tear film evaporation rate (amount of tears (grams or g) that evaporates over a surface area (m2) per hour (h)) assessment was performed using the VapoMeter as a non-invasive measurement of tear film evaporation over 10 seconds. Measurements were taken on both the right and left eyes after 8 hours of lens wear or no lens wear, as applicable. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance. | Day 1, Hour 8, each product |