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

Visco Vision Inc.1 site in 1 country60 target enrollmentJune 2015

ConditionsMyopia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Myopia
Sponsor: Visco Vision Inc.
Enrollment: 60
Locations: 1
Primary Endpoint: Visual Acuity
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

June 2015

End Date

November 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Visco Vision Inc.

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Visual Acuity

Time Frame: over all follow-up visits for 3 month study period

logMAR visual acuity (VA) over all visits.

Secondary Outcomes

Any Slit Lamp Finding > Grade 2(over all follow-up visits for the 3 month study period)
Subjective Response to Comfort, symptoms and complaints(over all follow-up visits for the 3 month study period)