Clinical Evaluation of Two Daily Wear Silicon Hydrogel Contact Lens

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate that the VISCO (Olifilcon A) soft contact lens could be prescribed as a supportive care for myopic persons.

Detailed Description
-----------------
This randomized controlled study will involve at least 50 evaluable subjects divided evenly among 5 study sites in Taiwan. Each study site will enroll 12 subjects at least. The ration of evaluable test subjects to control subjects will be 2 to 1. Subjects who have normal ocular health and conform to a set of standard criteria will wear one of the study lenses on two eyes and follow up for 3 months (90 days). Lenses will be assigned to subject according to a predetermined randomized order. It is necessary to remove contact lenses every day and replace after 30 days. Any unscheduled visit will be allowed when there is a medication necessary. The data for slit lamp findings, symptoms/problems/complaints, keratometry (K) reading, refractive changes (absolute value), visual acuity data, average wear time (AWT), discontinuations, and lens replacement will be collected to claim that the VISCO Soft Contact Lens is as safe and effective as BIOFINITY (comfilcon A) Soft Contact Lens (CooperVision).

Official Title
-----------------
A Prospective Randomized Controlled Study to Evaluate the Clinical Performance of VISCO Soft Contact Lens on a Daily Wear Basis

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Device: Biofinity soft contact lens
* Device: Visco soft contact lens


Participation Criteria
=================
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 -1.25 D astigmatism VA correctable to 20/25 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 solution use and/or normal contact lens wear. Cornea sensitivity low, high myopes, Keratoconus, dry eye with Schirmer Test < 5mm/5min or other physical condition that would contraindicate contact lens wear. Subjects have other active ocular or systemic disease that would contraindicate contact lens wear. Subjects have medications that would contraindicate contact lens wear. Females who are pregnant, breastfeeding, birth control pill taken or who intended to become pregnant over the course of the study. Current drug or alcohol use or dependence that would interfere with adherence to study requirements. Individuals participating in other clinical studies.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Visco soft contact lens<br>Olifilcon A, Daily wear, monthly disposable soft contact lens | Device: Visco soft contact lens<br>* Viso soft contact lens on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days.<br>|
| Active Comparator: Biofinity soft contact lens<br>Comfilcon A, Daily wear, monthly disposable soft contact lens | Device: Biofinity soft contact lens<br>* Biofinity soft contact lens on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | Visual acuity correctable to snellen 20/25 or better | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Slit Lamp Findings | Any slit lamp finding > Grade 2; Measured on a scale of 0-4 with 0=no findings and 4=severe findings | 3 month | 
| Symptoms, Problems and Complaints and Incidence Rate | Subjective Responses to comfort/symptoms/complaints were measured at every visit. 1=Severe Burning to 10=No Burning for each eye | 3 month |