DAILIES TOTAL1® Lubricity Post Wear

Study Overview
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Brief Summary
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The primary objective of the study is to demonstrate that the lubricity of DAILIES TOTAL1® (DT1) lenses after 16 hours of wear is equivalent to the lubricity of unworn DT1 lenses.

Detailed Description
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In this study, participants wore study lenses for 2 specified time periods (16 hours and 15 minutes, treatment sequence randomized) following which lenses were collected for ex vivo lubricity analysis. The ex vivo lubricity analysis was evaluated under a separate non-clinical protocol.

Official Title
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Evaluation of the Lubricity of DAILIES TOTAL1® Contact Lenses After Wear

Conditions
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Refractive Error

Intervention / Treatment
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* Device: Delefilcon A contact lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing and able to sign Informed Consent document. Adapted, current soft contact lens wearer. Requires contact lens powers within the specified range of -0.50 diopters (D) to -10.00D. Cylinder between 0.00D and -1.00D (inclusive) in both eyes at Visit 1 manifest refraction. Vision correctable to 20/25 or better in each eye at distance with study lenses. Willing to wear study lenses at least 16 waking hours in one day and attend all study visits. Able to be successfully fitted with study lenses. Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Any ocular infection, inflammation, abnormality or active disease that would contraindicate contact lens wear, as determined by the Investigator. Use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator. Use of artificial tears and rewetting drops during the study. Monocular (only one eye with functional vision) or fit with only one lens. Any abnormal ocular condition observed during the Visit 1 slit lamp examination. History of herpetic keratitis, ocular surgery, or irregular cornea. Pregnant. Participation in any clinical study within 30 days of Visit 1. 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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 16hrs/15mins<br>Delefilcon A contact lenses worn bilaterally (in both eyes) for 16 waking hours (1 day) in Period 1, followed by 15 minutes in Period 2. A fresh pair of lenses was dispensed for Period 2. | Device: Delefilcon A contact lenses<br>* Silicone hydrogel contact lenses<br>* Other names: DAILIES TOTAL1®;|
| Other: 15mins/16hrs<br>Delefilcon A contact lenses worn bilaterally for 15 minutes in Period 1, followed by 16 waking hours (1 day) in Period 2. A fresh pair of lenses was dispensed for Period 2. | Device: Delefilcon A contact lenses<br>* Silicone hydrogel contact lenses<br>* Other names: DAILIES TOTAL1®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Coefficient of Friction (CF) at 16 Hours Compared to Unworn | Worn contact lenses were removed from the participant's eye. The CF was calculated and compared to the CF for unworn contact lenses. A lower CF may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only. | Day 1 (for each period), 16 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Coefficient of Friction at 15 Minutes | Worn contact lenses were removed from the participant's eye and the CF was calculated. A lower CF may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only. | Day 1 (for each period), 15 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DT1, DAILIES TOTAL1®, Lubricity