Lubricity Post-Wear - Competitive Lenses Pilot

Study Overview
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Brief Summary
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The purpose of this study is to measure the coefficient of friction of three silicone hydrogel, daily disposable contact lenses after 16 hours of wear.

Detailed Description
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In this 3-treatment, 3-period, 6-sequence crossover study, each participant will wear all 3 products in randomized order, 1 product at a time, with a washout period of up to 7 days between treatment periods. Lenses will be collected for ex-vivo lubricity analysis. The ex-vivo lubricity analysis will be conducted under a separate non-clinical protocol.

Official Title
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Evaluation of the Lubricity of Daily Disposable Silicone Hydrogel Contact Lenses After Wear

Conditions
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Refractive Error

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must sign an informed consent form. Soft contact lens wearer (both eyes). Willing to wear study lenses at least 16 waking hours and attend all 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. Use of artificial tears and rewetting drops during the study. Monocular (only 1 eye with functional vision) or fit with only 1 lens. History of herpetic keratitis, ocular surgery, or irregular cornea. Pregnant. 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: TruEye, MyDay, clariti 1day<br>Narafilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3. Each product worn bilaterally (in both eyes) for 1 day (16 hours). | Device: Narafilcon A contact lenses<br>* Silicone hydrogel contact lenses for daily disposable wear<br>* Other names: 1-DAY ACUVUE® TruEye® (TruEye);Device: Stenfilcon A contact lenses<br>* Silicone hydrogel contact lenses for daily disposable wear<br>* Other names: MyDay™;Device: Somofilcon A contact lenses<br>* Silicone hydrogel contact lenses for daily disposable wear<br>* Other names: clariti® 1day;|
| Other: TruEye, clariti 1day, MyDay<br>Narafilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3. Each product worn bilaterally for 1 day (16 hours). | Device: Narafilcon A contact lenses<br>* Silicone hydrogel contact lenses for daily disposable wear<br>* Other names: 1-DAY ACUVUE® TruEye® (TruEye);Device: Stenfilcon A contact lenses<br>* Silicone hydrogel contact lenses for daily disposable wear<br>* Other names: MyDay™;Device: Somofilcon A contact lenses<br>* Silicone hydrogel contact lenses for daily disposable wear<br>* Other names: clariti® 1day;|
| Other: MyDay, TruEye, clariti 1day<br>Stenfilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3. Each product worn bilaterally for 1 day (16 hours). | Device: Narafilcon A contact lenses<br>* Silicone hydrogel contact lenses for daily disposable wear<br>* Other names: 1-DAY ACUVUE® TruEye® (TruEye);Device: Stenfilcon A contact lenses<br>* Silicone hydrogel contact lenses for daily disposable wear<br>* Other names: MyDay™;Device: Somofilcon A contact lenses<br>* Silicone hydrogel contact lenses for daily disposable wear<br>* Other names: clariti® 1day;|
| Other: MyDay, clariti 1day, TruEye<br>Stenfilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3. Each product worn bilaterally for 1 day (16 hours). | Device: Narafilcon A contact lenses<br>* Silicone hydrogel contact lenses for daily disposable wear<br>* Other names: 1-DAY ACUVUE® TruEye® (TruEye);Device: Stenfilcon A contact lenses<br>* Silicone hydrogel contact lenses for daily disposable wear<br>* Other names: MyDay™;Device: Somofilcon A contact lenses<br>* Silicone hydrogel contact lenses for daily disposable wear<br>* Other names: clariti® 1day;|
| Other: Clariti 1day, TruEye, MyDay<br>Somofilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3. Each product worn bilaterally for 1 day (16 hours). | Device: Narafilcon A contact lenses<br>* Silicone hydrogel contact lenses for daily disposable wear<br>* Other names: 1-DAY ACUVUE® TruEye® (TruEye);Device: Stenfilcon A contact lenses<br>* Silicone hydrogel contact lenses for daily disposable wear<br>* Other names: MyDay™;Device: Somofilcon A contact lenses<br>* Silicone hydrogel contact lenses for daily disposable wear<br>* Other names: clariti® 1day;|
| Other: Clariti 1day, MyDay, TruEye<br>Somofilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3. Each product worn bilaterally for 1 day (16 hours). | Device: Narafilcon A contact lenses<br>* Silicone hydrogel contact lenses for daily disposable wear<br>* Other names: 1-DAY ACUVUE® TruEye® (TruEye);Device: Stenfilcon A contact lenses<br>* Silicone hydrogel contact lenses for daily disposable wear<br>* Other names: MyDay™;Device: Somofilcon A contact lenses<br>* Silicone hydrogel contact lenses for daily disposable wear<br>* Other names: clariti® 1day;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Coefficient of Friction of Worn Lenses at 16 Hours | Worn contact lenses were removed from the participant's eye and the coefficient of friction was measured by the inclined plane method. A lower coefficient of friction may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only. | Day 1, Hour 16, each product | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Coefficient of Friction of Unworn Lenses | Unworn contact lenses were removed from the commercial packaging and the coefficient of friction of the unworn lenses was measured by the inclined plane method. A lower coefficient of friction may indicate higher contact lens lubricity. | Day 1 (each product) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contact lenses, Lubricity