Clinical Comparison of Two Daily Disposable Silicone Hydrogel Soft Contact Lens

Visco Vision

Status

Completed

Conditions

Myopia

Treatments

Device: Vistakon (narafilcon A)

Device: Si-Hy (olifilcon B)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02676258

1030313M

Details and patient eligibility

About

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.

Full description

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.

Enrollment

60 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.