Dehydration of Stenfilcon A Contact Lenses Versus Delefilcon A Contact Lenses

Study Overview
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Brief Summary
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The study will explore in vivo lens dehydration rates across a 12hr wear period for the study lenses.

Detailed Description
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The study will explore in vivo lens dehydration rates across a 12hr wear period for the study lenses. The primary outcome variable for this study is the loss in lens weight over the day, which will indicate the amount of dehydration that has occured.

Official Title
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Dehydration of Stenfilcon A Contact Lenses Versus Delefilcon A Contact Lenses

Conditions
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Myopia

Intervention / Treatment
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* Device: stenfilcon 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; Is a current wearer of soft contact lenses and has worn them (any brand) more than 3 months. Is able to wear lenses for at least 12 hours a day. Exclusion Criteria: Is participating in any concurrent clinical 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 the diagnostic pharmaceuticals to be used in the study; Has undergone refractive error surgery; *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: 17 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stenfilcon A<br>Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design). | Device: stenfilcon A<br>* Each subject randomized to wear either the test or control in either the left of right eye.<br>Device: delefilcon A<br>* Each subject randomized to wear either the test or control in either the left of right eye.<br>|
| Active Comparator: delefilcon A<br>Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design). | Device: stenfilcon A<br>* Each subject randomized to wear either the test or control in either the left of right eye.<br>Device: delefilcon A<br>* Each subject randomized to wear either the test or control in either the left of right eye.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Change in Water Content (Mean) of Stenfilcon A and Delefilcon A | Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC). | 12 Hours of Wear | 
| Absolute Change in Water Content (Median) of Stenfilcon A and Delefilcon A | Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC). | 12 Hours of Wear | 
| Moisture Retention (Mean) of Stenfilcon A and Delefilcon A | Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD). | 12 Hours of Wear | 
| Moisture Retention (Median) of Stenfilcon A and Delefilcon A | Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD). | 12 Hours of Wear | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Comfort of Stenfilcon A and Delefilcon A | Subjective ratings for stenfilcon A and delefilcon A assessed at every hour up to 12 hours. (Scale 0-100, 0=very poor 100=excellent) | Up to 12 Hours of Wear |