Clinical Evaluation of Two Daily Wear Silicon Hydrogel Contact Lens

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

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Visco soft contact lens; Device: Biofinity soft contact lens

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).

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Visco soft contact lens; Olifilcon A, Daily wear, monthly disposable soft contact lens	Device: Visco soft contact lens; 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.
Active Comparator: Biofinity soft contact lens; Comfilcon A, Daily wear, monthly disposable soft contact lens	Device: Biofinity soft contact lens; 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.

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

Collaborators and Investigators

• Sponsor: Visco Vision Inc.
• Investigators: Principal Investigator: Huey Chuan Cheng, MD. MS, Mackey Memorial Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: January 29, 2015
• First Submitted That Met QC Criteria: January 29, 2015
• First Posted (Estimate): February 3, 2015

Study Record Updates

• Last Update Posted (Actual): April 14, 2017
• Last Update Submitted That Met QC Criteria: March 2, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: 1000601M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No