Clinical Evaluation of Two Daily Wear Silicon Hydrogel Contact Lens

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Biofinity soft contact lens; Device: Visco soft contact lens

• Registration Number: NCT02354924
• Lead Sponsor: Visco Vision Inc.

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).

Study Timeline

• Study Start: 2013-06
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Study First Submitted: 2015-01-29
• Study First Submitted QC: 2015-01-29
• Study First Posted: 2015-02-03
• Results First Submitted: 2016-11-01
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-02
• Last Update Submitted: 2017-03-02
• Results First Posted: 2017-04-14
• Last Update Posted: 2017-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biofinity soft contact lens	Biofinity soft contact lens	Comfilcon A, Daily wear, monthly disposable soft contact lens
Visco soft contact lens	Visco soft contact lens	Olifilcon A, Daily wear, monthly disposable soft contact lens

Primary Outcome Measures

Name	Time	Method
Visual Acuity	3 months	Visual acuity correctable to snellen 20/25 or better

Secondary Outcome Measures

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