Silicone Hydrogel Contact Lenses on Low Astigmatism in Japan

Study Overview
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Brief Summary
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This study seeks to evaluate the clinical performance of a recently released contact lens designed to correct astigmatism to an established contact lens that has historically been used in these patients.

Official Title
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The Clinical Performance of the Silicone Hydrogel Contact Lens on Low to Moderate Astigmatism in Japan

Conditions
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Refractive Error, Myopia, Astigmatism

Intervention / Treatment
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* Device: senofilcon A toric soft contact lens
* Device: senofilcon A sphere soft contact lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject is 18 to 39 years of age. (Parental consent is required for a minor child i.e. under the age of 20.) The subject has signed an informed consent with his/her own judgement for participation in the study. The subject currently is a habitual wearer of spherical or toric daily-wear soft contact lenses, excluding daily disposables, in daily wear bases. Exclusion Criteria: The subject has any ocular or systemic allergies that interfere with contact lens wear. The subject has dry eye and lacrimal apparatus disease that could interfere with contact lens wear. The subject has any systemic disease or autoimmune disease that interferes with contact lens wear. The subject has corneal edema, neovascularization, corneal staining or other ocular abnormalities (Grade 3 or above) that clinically apparently interfere with contact lens wear. The subject has any anterior segment eye disease (palpebral abnormalities, corneal hypesthesia, corneal epithelial defect, bulbar conjunctival hyperemia, etc.) that clinically apparently interferes with contact lens wear. The subject has a history of solution reactions to the chemical cleaner/disinfectant to be used in this study, as far as known to the subject. The subject has ocular infection. The subject has ocular inflammation (including acute/subacute anterior segment inflammations and uveitis). The subject has corneal distortion resulting from previous experience of hard contact lens wear. The subject has infectious disease (pneumonia, tuberculosis, etc.) or immunosuppressive disease (HIV positive etc.), as far as known to the subject. The subject has diabetes, as far as known to the subject. The subject is pregnant or in the lactation period, as far as known to the subject. The subject uses any eye remedies (excluding artificial tear substitutes or hyaluronic acid drops for reducing dryness while wearing contact lenses). The subject had any ocular trauma or surgery within 8 weeks prior to participation in the study. The subject is a wearer of hard contact lenses (including rigid gas permeable). The subject is exposed to a dry environment on a constant basis. The subject is exposed to a living environment where dust, chemicals, etc. can easily enter the eye. The subject is unable to follow the principal investigator's instructions. The subject is unable to follow lens hygiene procedures necessary for contact lens wear.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: spherical contact lens<br>Subjects will wear and evaluate a spherical soft contact lens daily for 2 weeks | Device: senofilcon A sphere soft contact lens<br>* contact lens<br>* Other names: ACUVUE OASYS;|
| Experimental: toric contact lens<br>Subjects will wear and evaluate a toric soft contact lens daily for 2 weeks | Device: senofilcon A toric soft contact lens<br>* contact lens<br>* Other names: ACUVUE OASYS for Astigmatism;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject-reported satisfaction for vision | Scale of 0 to 100, were 0=extremely poor and 100=Excellent | After 2 weeks of lens wear | 
| Subject-reported satisfaction for comfort. | Scale of 0 to 100, were 0=extremely poor and 100=Excellent | After 2 weeks of lens wear | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject preference for lens type. |  | After 2 weeks of lens wear. |