Clinical Comparison of Two Daily Disposable Silicone Hydrogel Soft Contact Lens

Study Overview
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Brief Summary
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The objective of this study is to evaluate a new daily disposable silicone hydrogel soft contact lens by comparing to an existing daily disposable soft contact lens.

Detailed Description
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This study is designed to evaluate the performance of the olifilcon B contact lens to demonstrate substantial equivalence to the narafilcon A for regulatory requirement.

Official Title
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A Prospective Randomized Controlled Study to Evaluate the Clinical Performance of Si-Hy Silicone Hydrogel Soft Contact Lens

Conditions
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Myopia

Intervention / Treatment
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* Device: Si-Hy (olifilcon B)
* Device: Vistakon (narafilcon A)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject should have normal eyes and use no ocular medications Subject with -1.00 to -10.00 D myopia, less than 2.00 D astigmatism VA correctable to Log MAR 0.1 or better. Willing to comply with all study procedures and be available for the duration of the study. Provide signed and dated informed consent form. Exclusion Criteria: Subjects have history of allergies that would contraindicate normal contact lens wear. Subjects have other active ocular or systemic disease such as, but not limited to : anterior uveitis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, sclerodermas, keratoconus or type II diabetes. Subjects have medications that would contraindicate contact lens wear. Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the next 3 month. Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. Any active participation in another clinical trial within 30 days prior to this study. The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures. A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates or fungal infections. A history of papillary conjunctivitis that has interfered with contact lens wear.

Ages Eligible for Study
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Minimum Age: 20 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Si-Hy soft contact lens<br>olifilon B daily disposable soft contact lens | Device: Si-Hy (olifilcon B)<br>* Wear Si-Hy silicone hydrgel soft contact lens for 3 months<br>|
| Active Comparator: Vistakon soft contact lens<br>narafilcon A daily disposable soft contact lens | Device: Vistakon (narafilcon A)<br>* Wear Vistakon soft contact lens for 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | logMAR visual acuity (VA) over all visits. | over all follow-up visits for 3 month study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any Slit Lamp Finding > Grade 2 | All dispensed eyes over all follow-up visits. Measured on a scale of 0-4 with 0=no findings and 4=sever findings. | over all follow-up visits for the 3 month study period | 
| Subjective Response to Comfort, symptoms and complaints | subjective ratings of comfort, symptom and complaints using a scale of 0=severe stinging/Burning to 10=No stinging/Burning for each eye; 0 represented the least favorable rating and a 100 represented the most favorable rating. | over all follow-up visits for the 3 month study period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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silicone hydrogel daily disposable soft contact lens