Clinical Evaluation of Stenfilcon A Contact Lenses

Study Overview
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Brief Summary
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This study is to evaluate the fitting performance of stenfilcon A contact lens (test) compared to narafilcon A contact lens (control).

Detailed Description
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This study is to evaluate the fitting performance of stenfilcon A contact lens (test) compared to narafilcon A contact lens (control) over 3 hour of wear time in a Japanese population.

Official Title
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Clinical Evaluation of CooperVision MyDay Lenses

Conditions
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Myopia

Intervention / Treatment
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* Device: stenfilcon A lens
* Device: narafilcon A lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A person is eligible for inclusion in the study if he/she: Is Japanese Has had a self-reported oculo-visual examination in the last two years. Is at least 18 years of age and has full legal capacity to volunteer. Has read and understood the informed consent letter. Is willing and able to follow instructions and maintain the appointment schedule. Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected. Currently wears soft contact lenses. Has clear corneas and no active ocular disease. Exclusion Criteria: A person will be excluded from the study if he/she: Has never worn contact lenses before. Has any systemic disease affecting ocular health. Is using any systemic or topical medications that will affect ocular health. Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses. Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye. Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars. Is aphakic. Has undergone corneal refractive surgery. Is participating in any other type of eye related clinical or research study.

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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This will be a non-dispensing, randomized, contralateral study comparing a test lens against the appropriate control lens.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stenfilcon A lens<br>MyDay contact lens | Device: stenfilcon A lens<br>* contact lens<br>* Other names: MyDay, test;|
| Active Comparator: narafilcon A lens<br>1-Day Acuvue TruEye | Device: narafilcon A lens<br>* contact lens<br>* Other names: 1-day Acuvue TruEye, control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Movement | Movement of lens after blink: (Categories = Tight, Slightly tight, Optimum, Slightly loose, Loose) | 5 minutes | 
| Lens Movement | Movement of lens after blink: (Categories = Tight, Slightly tight, Optimum, Slightly loose, Loose) | 3hrs | 
| Horizontal Lens Centration | Centration of lens horizontally: (Grades = Temporal, Slightly temporal, Centered, Slightly Nasal, Nasal) | 5 minutes | 
| Horizontal Lens Centration | Centration of lens horizontally: (Grades = Temporal, Slightly temporal, Centered, Slightly Nasal, Nasal) | 3hrs | 
| Vertical Lens Centration | Centration of lens horizontally: (Grades = Superior, Slightly superior, Center, Slightly inferior, Inferior) | 5 minutes | 
| Vertical Lens Centration | Centration of lens horizontally: (Grades = Superior, Slightly superior, Centered, Slightly inferior, Inferior) | 3hrs | 
| Corneal Coverage | Does lens cover the cornea: (Yes, No) | 5 minutes | 
| Corneal Coverage | Does lens cover the cornea: (Yes, No) | 3hrs | 
| Lens Lag | Movement after looking right and left: (Grades = Move along with cornea, slight delay, delay) | 5 minutes | 
| Lens Lag | Movement after looking right and left: (Grades = Move along with cornea, slight delay, delay) | 3hrs | 
| Overall Fitting Performance | Lens fit performance: (Grades: Optimum, Good, Acceptable, Unacceptable) | 5 minutes | 
| Overall Fitting Performance | Lens fit performance: (Grades: Optimum, Good, Acceptable, Unacceptable) | 3hrs | 
| Investigator Fit Preference | Lens fit preference: (Grades: Prefer stenfilcon A strongly, Prefer stenfilcon A slightly, Either, Prefer narafilcon A slightly, Prefer narafilcon A strongly) | 5 minutes | 
| Investigator Fit Preference | Lens fit preference: (Grades: Prefer stenfilcon A strongly, Prefer stenfilcon A slightly, Either, Prefer narafilcon A slightly, Prefer narafilcon A strongly) | 3hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort | Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable)) | Baseline | 
| Comfort | Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable)) | 5 Minutes | 
| Comfort | Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable)) | 3 hours | 
| Dryness | Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry)) | Baseline | 
| Dryness | Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry)) | 5 minutes | 
| Dryness | Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry)) | 3 hours | 
| Stinging/Burning | Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning)) | Baseline | 
| Stinging/Burning | Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning)) | 5 minutes | 
| Stinging/Burning | Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning)) | 3 hours | 
| Edge/Lens Awareness | Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness)) | Baseline | 
| Edge/Lens Awareness | Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness)) | 5 minutes | 
| Edge/Lens Awareness | Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness)) | 3 hours | 
| Subjective Lens Preference | Lens preference (stenfilcon A, Either, Neither, narafilcon A) | Baseline | 
| Subjective Lens Preference | Lens preference (stenfilcon A, Either, Neither, narafilcon A) | 5 minutes | 
| Subjective Lens Preference | Lens preference (stenfilcon A, Either, Neither, narafilcon A) | 3 hours |