Evaluation of the Performance of Different Daily Disposable Lens Designs in Habitual Soft Contact Lens Wearers

Study Overview
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Brief Summary
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The main objective of the study is to refit existing soft lens wearers with two different daily disposable contact lens types, Lens A and Lens B, to determine their performance after one week of wear.

Detailed Description
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This study is a prospective, bilateral eye, double-masked, randomized, 1-week cross-over, daily-wear design involving two different daily disposable lens types. Each lens type will be worn for approximately one week, during which participants record their subjective lens-wear experience.

Official Title
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Evaluation of the Performance of Different Daily Disposable Lens Designs in Habitual Soft Contact Lens Wearers

Conditions
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Myopia

Intervention / Treatment
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* Device: stenfilcon A - (Test lens)
* Device: kalifilcon A - (Control Lens)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is at least 18 years of age and has full legal capacity to volunteer; Has read and signed an information consent letter; Self reports having a full eye examination in the previous two years; Anticipates being able to wear the study lenses for at least 8 hours a day, 7 days a week; Is willing and able to follow instructions and maintain the appointment schedule; Habitually wears soft contact lenses, for the past 3 months minimum; Has refractive astigmatism no higher than -0.75DC in each eye; Can be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens parameters are sphere -1.00 to -6.00D, 0.25D steps). Exclusion Criteria: Is participating in any concurrent clinical or research study; Habitually wears one of the study contact lenses; Has any known active* ocular disease and/or infection that contraindicates contact lens wear; 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 contact lens wear or a study outcome variable; Has known sensitivity to the diagnostic sodium fluorescein used in the study; Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment; Has undergone refractive error surgery or intraocular surgery.

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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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stenfilcon A - (Test lens)<br>Subjects will be randomized to wear test lenses for one week then cross-over to the control lenses for one week. | Device: stenfilcon A - (Test lens)<br>* Subjects will be randomized to wear test lenses for one week.<br>Device: kalifilcon A - (Control Lens)<br>* Subjects will be randomized to wear control lenses for one week.<br>|
| Active Comparator: kalifilcon A - (Control Lens)<br>Subjects will be randomized to wear control lenses for one week then cross-over to the test lenses for one week. | Device: stenfilcon A - (Test lens)<br>* Subjects will be randomized to wear test lenses for one week.<br>Device: kalifilcon A - (Control Lens)<br>* Subjects will be randomized to wear control lenses for one week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Wettability | Lens wettability on a 0 to 4 descriptive scale, 0.5 steps (0 - Very poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 - Poor: Irregular surface appearance, drying time << blink time, 2 - Acceptable: Smooth surface appearance immediately after the blink becoming irregular after a while, drying time ≤ blink time, 3 - Good: Typical soft lens appearance with long drying time, 4 - Excellent: Appearance similar to a healthy cornea with very long drying time) | Baseline - after 2 hours of lens wear | 
| Lens Wettability | Lens wettability on a 0 to 4 descriptive scale, 0.5 steps (0 - Very poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 - Poor: Irregular surface appearance, drying time << blink time, 2 - Acceptable: Smooth surface appearance immediately after the blink becoming irregular after a while, drying time ≤ blink time, 3 - Good: Typical soft lens appearance with long drying time, 4 - Excellent: Appearance similar to a healthy cornea with very long drying time) | 1 week |