Performance Evaluation of Daily Disposable Contact Lenses in Habitual Lens Wearers Who Use Digital Devices Frequently

Study Overview
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Brief Summary
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The goal of this study is to compare the performance of two daily disposable silicone hydrogel lenses.

Detailed Description
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This study is prospective, bilateral eye, double masked, randomized, 1 week cross-over, daily wear design involving in two different daily disposable lens types. Each lens type will be worn for approximately one week.

Official Title
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Performance Evaluation of Different Daily Disposable Contact Lenses in Habitual Lens Wearers Who Report Frequent Use of Digital Devices

Conditions
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Myopia

Intervention / Treatment
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* Device: Control Contact Lens (stenfilcon A)
* Device: Test Contact Lens (senofilcon A)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is between 18 and 35 years of age (inclusively) 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; Self-reports spending on most days at least 6 hours cumulative (not necessarily in one single stretch) using digital devices such as a computer, laptop, tablet, e-reader, smartphone; 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; No more than 1/3 of participants should be habitual wearer of MyDay or MyDay Energys No more than 1/3 of participants should be habitual wearer of ACUVUE® OASYS MAX 1-Day or ACUVUE® OASYS 1-Day. 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; 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
Maximum Age: 35 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: Control Contact Lens, Then Test Contact Lens<br>Participants will wear control contact lenses for one week and then crossover to test contact lenses for one week. | Device: Control Contact Lens (stenfilcon A)<br>* One week wear<br>Device: Test Contact Lens (senofilcon A)<br>* One week wear<br>|
| Experimental: Test Contact Lens, Then Control Contact Lens<br>Participants will wear test contact lenses for one week and then crossover to control contact lenses for one week. | Device: Control Contact Lens (stenfilcon A)<br>* One week wear<br>Device: Test Contact Lens (senofilcon A)<br>* One week wear<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Handling on Removal | Lens Handling on Removal using a 0-100 scale (0= very difficult, 100= very easy) | 6 days of wear |