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Clinical Comparison of Two Daily Disposable Silicone Hydrogel Soft Contact Lens

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Si-Hy (olifilcon B)
Vistakon (narafilcon A)
Sponsored by
Visco Vision Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Myopia focused on measuring silicone hydrogel daily disposable soft contact lens

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 2.00 D astigmatism
  • VA correctable to Log MAR 0.1 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 "normal" contact lens wear.
  • Subjects have other active ocular or systemic disease such as, but not limited to : anterior uveitis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, sclerodermas, keratoconus or type II diabetes.
  • Subjects have medications that would contraindicate contact lens wear.
  • Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the next 3 month.
  • Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  • Any active participation in another clinical trial within 30 days prior to this study.
  • The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
  • A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates or fungal infections.
  • A history of papillary conjunctivitis that has interfered with contact lens wear.

Sites / Locations

  • MayKay Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Si-Hy soft contact lens

Vistakon soft contact lens

Arm Description

olifilon B daily disposable soft contact lens

narafilcon A daily disposable soft contact lens

Outcomes

Primary Outcome Measures

Visual Acuity
logMAR visual acuity (VA) over all visits.

Secondary Outcome Measures

Any Slit Lamp Finding > Grade 2
All dispensed eyes over all follow-up visits. Measured on a scale of 0-4 with 0=no findings and 4=sever findings.
Subjective Response to Comfort, symptoms and complaints
subjective ratings of comfort, symptom and complaints using a scale of 0=severe stinging/Burning to 10=No stinging/Burning for each eye; 0 represented the least favorable rating and a 100 represented the most favorable rating.

Full Information

First Posted
January 30, 2016
Last Updated
July 5, 2016
Sponsor
Visco Vision Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02676258
Brief Title
Clinical Comparison of Two Daily Disposable Silicone Hydrogel Soft Contact Lens
Official Title
A Prospective Randomized Controlled Study to Evaluate the Clinical Performance of Si-Hy Silicone Hydrogel Soft Contact Lens
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Visco Vision Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to evaluate a new daily disposable silicone hydrogel soft contact lens by comparing to an existing daily disposable soft contact lens.
Detailed Description
This study is designed to evaluate the performance of the olifilcon B contact lens to demonstrate substantial equivalence to the narafilcon A for regulatory requirement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
silicone hydrogel daily disposable soft contact lens

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Si-Hy soft contact lens
Arm Type
Experimental
Arm Description
olifilon B daily disposable soft contact lens
Arm Title
Vistakon soft contact lens
Arm Type
Active Comparator
Arm Description
narafilcon A daily disposable soft contact lens
Intervention Type
Device
Intervention Name(s)
Si-Hy (olifilcon B)
Intervention Description
Wear Si-Hy silicone hydrgel soft contact lens for 3 months
Intervention Type
Device
Intervention Name(s)
Vistakon (narafilcon A)
Intervention Description
Wear Vistakon soft contact lens for 3 months
Primary Outcome Measure Information:
Title
Visual Acuity
Description
logMAR visual acuity (VA) over all visits.
Time Frame
over all follow-up visits for 3 month study period
Secondary Outcome Measure Information:
Title
Any Slit Lamp Finding > Grade 2
Description
All dispensed eyes over all follow-up visits. Measured on a scale of 0-4 with 0=no findings and 4=sever findings.
Time Frame
over all follow-up visits for the 3 month study period
Title
Subjective Response to Comfort, symptoms and complaints
Description
subjective ratings of comfort, symptom and complaints using a scale of 0=severe stinging/Burning to 10=No stinging/Burning for each eye; 0 represented the least favorable rating and a 100 represented the most favorable rating.
Time Frame
over all follow-up visits for the 3 month study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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 2.00 D astigmatism VA correctable to Log MAR 0.1 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 "normal" contact lens wear. Subjects have other active ocular or systemic disease such as, but not limited to : anterior uveitis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, sclerodermas, keratoconus or type II diabetes. Subjects have medications that would contraindicate contact lens wear. Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the next 3 month. Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. Any active participation in another clinical trial within 30 days prior to this study. The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures. A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates or fungal infections. A history of papillary conjunctivitis that has interfered with contact lens wear.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huey Chuan Cheng, MD MS
Organizational Affiliation
Mackay Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
MayKay Memorial Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Comparison of Two Daily Disposable Silicone Hydrogel Soft Contact Lens

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