The Clinical Study of Silicone Hydrogel Daily Disposable Stenfilcon A Toric Lens

Study Overview
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Brief Summary
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The aim of this study is to evaluate the clinical performance of stenfilcon A toric lenses compared with etafilcon A toric lenses for astigmatism. If it is valuable, the clinical performance of stenfilcon A toric lens is also evaluated compared with habitual lenses.

Detailed Description
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This is a multi-sites, 50 subjects, randomized, open labeled, bilateral wear, dispensing study. Participants will be randomized to wear first lens pair for two weeks, and then crossover to second lens pair for two weeks.

Official Title
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The Clinical Study of Silicone Hydrogel Daily Disposable Stenfilcon A Toric Lens

Conditions
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Astigmatism

Intervention / Treatment
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* Device: stenfilcon A
* Device: etafilcon A


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 years of age and 42 years of age. Soft contact lens wearers who are not required to have Presbyopic correction. Soft contact lens wearers without trouble. Soft contact lens wearers who have the correctable astigmatism by lenses used in this study in the both eyes. Has a prescribed SCL (Soft Contact Lens) power within the range of powers of the SCL for astigmatism which is used in this study. Can achieve a corrected visual acuity of 1.0 or better. Can read and understand the study information document, and sign the participation consent form. Can visit the clinic at designated examination visits. Has received periodical examinations at an eye clinic within the past two years. Exclusion Criteria: A person will be excluded from the study if he/she: Has a systemic disease that may affect the ocular health. Is pregnant or lactating. Has received a systemic or local medication that may affect this study. Has an infectious eye disease. Has eye and systemic active allergic diseases that interferes with SCL wear. Has an eye disease which is clinically judged to be severe such as corneal vascularization, limbal hyperemia, and corneal epithelium disorder Has a history of hard contact lens wear within 30 days. Is currently participating in another clinical research study. Has undergone refractive surgery.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stenfilcon A<br>Participants will be randomized to wear stenfilcon A lens pair for two weeks during the cross over study. | Device: stenfilcon A<br>* contact lens<br>|
| Active Comparator: etafilcon A<br>Participants will be randomized to wear etafilcon A lens pair for two weeks during the cross over study. | Device: etafilcon A<br>* contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort | Wearing comfort (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0= extremely uncomfortable cannot wear at all, 10=very comfortable and feel no lens at all | 2 weeks | 
| Dryness | Dryness (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=extremely dried and cannot wear lens, 10=feel no dryness at all | 2 weeks | 
| Clarity of Vision | Clarity of vision (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=blur vision and cannot see at all, 10=very clear with no blur vision at all | 2 weeks | 
| Stability of Vision | Stability of vision (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=unstable vision and cannot see at all, 10=always stable vision | 2 weeks | 
| Lens Handling | Lens handling for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=cannot handle at all, 10=no problem at all | 2 weeks | 
| Overall Satisfaction | Overall satisfaction for stenfilcon A and etafilcon A toric lens pair is assessed. scale 0-10, 0=extremely un-satisfy, 10=very satisfy | 2 weeks |