Back to results

Clinical Evaluation of Two Daily Wear Silicon Hydrogel Contact Lens

Primary Purpose

Myopia

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Biofinity soft contact lens

Visco soft contact lens

About this trial

This is an interventional supportive care trial for Myopia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Visco soft contact lens

Biofinity soft contact lens

Arm Description

Olifilcon A, Daily wear, monthly disposable soft contact lens

Comfilcon A, Daily wear, monthly disposable soft contact lens

Outcomes

Primary Outcome Measures

Visual Acuity

Visual acuity correctable to snellen 20/25 or better

Secondary Outcome Measures

Slit Lamp Findings

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

Subjective Responses to comfort/symptoms/complaints were measured at every visit. 1=Severe Burning to 10=No Burning for each eye

Full Information

NCT ID

NCT02354924

First Posted

January 29, 2015

Last Updated

March 2, 2017

Sponsor

Visco Vision Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02354924

Brief Title

Clinical Evaluation of Two Daily Wear Silicon Hydrogel Contact Lens

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

June 2013 (undefined)

Primary Completion Date

November 2013 (Actual)

Study Completion Date

November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Visco Vision Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myopia

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Visco soft contact lens

Arm Type

Experimental

Arm Description

Olifilcon A, Daily wear, monthly disposable soft contact lens

Arm Title

Biofinity soft contact lens

Arm Type

Active Comparator

Arm Description

Comfilcon A, Daily wear, monthly disposable soft contact lens

Intervention Type

Device

Intervention Name(s)

Biofinity soft contact lens

Intervention Description

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

Intervention Name(s)

Visco soft contact lens

Intervention Description

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.

Primary Outcome Measure Information:

Title

Visual Acuity

Description

Visual acuity correctable to snellen 20/25 or better

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Slit Lamp Findings

Description

Any slit lamp finding > Grade 2; Measured on a scale of 0-4 with 0=no findings and 4=severe findings

Time Frame

3 month

Title

Symptoms, Problems and Complaints and Incidence Rate

Description

Subjective Responses to comfort/symptoms/complaints were measured at every visit. 1=Severe Burning to 10=No Burning for each eye

Time Frame

3 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Huey Chuan Cheng, MD. MS

Organizational Affiliation

Mackey Memorial Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Clinical Evaluation of Two Daily Wear Silicon Hydrogel Contact Lens

We'll reach out to this number within 24 hrs