Performance of Wearers of Stenfilcon A Contact Lenses After A Refit With Test Lenses

Study Overview
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Brief Summary
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The aim of this study is to determine if habitual or adapted wearers of stenfilcon A control contact lenses can be refit into test lenses and be successful after one week of daily wear.

Detailed Description
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This study is a prospective, multi-center, open label, bilateral, daily wear, one week dispensing study comparing performance of wearers of stenfilcon A control contact lenses after refit with test contact lenses.

Official Title
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Performance of Wearers of MyDay Sphere Lenses After A Refit With MyDay Energys Lenses for One Week

Conditions
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Myopia

Intervention / Treatment
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* Device: Test lens
* Device: control 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 between 18 and 35 years of age (inclusive) Has read and signed the informed consent letter Is willing and anticipated to follow instructions and maintain the appointment schedule Habitually wears soft spherical contact lenses with a power between -1.00D to -6.00D (inclusive) for a minimum 5 days per week, 10 hours per day and anticipates no difficulty wearing contact lenses for 7 days per week, 10 hours per day. Habitually wears or is able to be adequately refit into MyDay Sphere lenses Demonstrates an acceptable fit with the study lenses Is correctable to a distance visual acuity of 0.20 logMAR (approximately 20/30) or better (in each eye) with the study contact lenses Uses digital devices, (e.g. computer, tablet, smart phone, iPad), for more than 4 hours a day, 5 days a week. Manifest cylindrical spectacle refraction does not exceed -0.75DC in either eye Has clear corneas and no active ocular disease Has a contact lens refraction that fits within the available parameters of the study lenses. Exclusion Criteria: A person will be excluded from the study if he/she: Is participating in any concurrent clinical research study Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day) Has a systemic condition that, in the opinion of the investigator, may affect the study measures Is using any systemic or topical medications that in the opinion of the investigator may affect the study measures. Presents with slit lamp findings or clinically significant anterior segment abnormalities that would contraindicate contact lens wear such as: Pathological dry eye or associated findings Significant pterygium, pinguecula, or corneal scars within the visual axis Neovascularization > 0.75 mm in from of the limbus Giant papillary conjunctivitis (GCP) worse than grade 1 Anterior uveitis or iritis (or history in past year) Seborrheic eczema of eyelid region, Seborrheic conjunctivitis History of corneal ulcers or fungal infections Poor personal hygiene Has a known history of corneal hypoesthesia (reduced corneal sensitivity) Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study Has aphakia, keratoconus or a highly irregular cornea. Has presbyopia or has dependence on spectacles for near work over the contact lenses. Has undergone refractive surgery. Is pregnant, lactating or planning a pregnancy (by verbal communication) at the time of enrollment Has participated in any other type of eye related clinical or research study within the last 7 days Is habitually using rewetting/ lubricating eye drops (more than once per day)

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stenfilcon A / Test lens<br>All subjects will first wear stenfilcon A contact lenses for one week, then refitted with test contact lenses to wear for one week. | Device: Test lens<br>* contact lens<br>* Other names: stenfilcon A Test lens;Device: control lens<br>* contact lens<br>* Other names: stenfilcon A Control lens;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Lens Fit Acceptance | Overall lens fit acceptance on a scale of 0-4, 0.5 steps (Scale: 0=should not be worn, 4=perfect) | Baseline (After 10 minutes of lens dispense) | 
| Overall Lens Fit Acceptance | Overall lens fit acceptance on a scale of 0-4, 0.5 steps (Scale: 0=should not be worn, 4=perfect) | 1 week on each study lenses | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Centration | Lens centration was assessed on a 3 point scale (1-Optimum, 2- Decentration acceptable, 3-Decentration unacceptable) | Baseline - After 10 minutes of lens dispense | 
| Lens Centration | Lens centration was assessed on a 3 point scale (1-Optimum, 2- Decentration acceptable, 3-Decentration unacceptable) | 1 week on each study lenses | 
| Post-blink Movement | Post-blink movement assessed on a scale of 0-4, 1 step size (Scale: 0=Insufficient, 1=Minimal, 2=Optimal, 3=Moderate, 4=Excessive) | Baseline (after 10 minutes of lens dispense) | 
| Post-blink Movement | Post-blink movement assessed on a scale of 0-4, 1 step size (Scale: 0=Insufficient, 1=Minimal, 2=Optimal, 3=Moderate, 4=Excessive) | 1 week on each study lenses |