Clinical Evaluation of Two Daily Wear Silicon Hydrogel Contact Lens

NCT ID: NCT02354924

Last Updated: 2017-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2013-11-30

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).

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Visco soft contact lens

Olifilcon A, Daily wear, monthly disposable soft contact lens

Group Type: EXPERIMENTAL

Visco soft contact lens

Intervention Type: DEVICE

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.

Biofinity soft contact lens

Comfilcon A, Daily wear, monthly disposable soft contact lens

Group Type: ACTIVE_COMPARATOR

Biofinity soft contact lens

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Visco Vision Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huey Chuan Cheng, MD. MS

Role: PRINCIPAL_INVESTIGATOR

Mackey Memorial Hospital

Other Identifiers

1000601M

Identifier Type: -

Identifier Source: org_study_id