Clinical Evaluation of Two Daily Wear Silicon Hydrogel Contact Lens

Visco Vision

Status

Completed

Conditions

Myopia

Treatments

Device: Visco soft contact lens

Device: Biofinity soft contact lens

Study type

Interventional

Funder types

Industry

Identifiers

NCT02354924

1000601M

Details and patient eligibility

About

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.

Full 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).

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 -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.