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the Clinical Performance of the Oxysoft Daily Disposable Silicone Hydrogel Soft Contact Lens

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
oxysoft (olifilcon C)
Si-Hy (olifilcon B)
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 contact lens material, silicon hydrogel

Eligibility Criteria

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

Inclusion Criteria:

  • Subject should have normal eye and use no ocular medications
  • VA correctable to 0.1 LogMAR or better, with spherical lenses ranging in power from -1.00 to -10.00 D myopia, astigmatism =< 2.00 D
  • 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, slip lamp findings greater than grade I (such as cornea or interstitial edema).
  • Subjects have medications that would contraindicate contact lens wear.
  • 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.
  • Any active participation in another clinical trial within 30 days prior to this study.
  • Have had any cornea surgery.
  • Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the next 1 month.
  • Monocular or monovision fits
  • Alcoholic or Drug Abused.

Sites / Locations

  • Taipei TzuChi Hopsital, Buddhist Tzu Chi Medical Foundation
  • Tri-Service General Hospital_Tingjhou
  • MayKay Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oxysoft

SiHy

Arm Description

olifilcon C, daily disposable soft contact lens, 1 month

olifilcon B, dialy disposable soft contact lens, 1 month

Outcomes

Primary Outcome Measures

Log MAR visual acuities
The primary efficacy will be Log MAR visual acuities (VA) of 0.1 or better.

Secondary Outcome Measures

slit lamp findings
Any slit lamp findings > grade 2 [ Time Frame: over all follow-up visits for the 1 month ] slit lamp findings on all dispensed eyes over all follow-up visits. Measured on a scale of 0-4 with 0=no findings and 4=sever findings.

Full Information

First Posted
April 29, 2019
Last Updated
April 30, 2019
Sponsor
Visco Vision Inc.
Collaborators
Jens Medical Consulting Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03934788
Brief Title
the Clinical Performance of the Oxysoft Daily Disposable Silicone Hydrogel Soft Contact Lens
Official Title
A Prospective Randomized Controlled Study to Evaluate the Clinical Performance of OxySoft Silicone Hydrogel Soft Contact Lens
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 26, 2018 (Actual)
Primary Completion Date
November 29, 2018 (Actual)
Study Completion Date
November 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Visco Vision Inc.
Collaborators
Jens Medical Consulting Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to demonstrate that the OxySoft silicone hydrogel soft contact lens could be prescribed as a supportive care for myopes.
Detailed Description
This is a double blind randomized control study to evaluate a daily disposable contact lens. It is planned to have 30 evaluable subjects at least divided evenly among 3 independent PIs. Each PI will enroll 12 subjects at least. The ration of evaluable test subjects to control subjects will be 2 to 1. The study lens will be dispensed randomly to subjects who have normal ocular health and conform to a set of criteria. It is necessary to wear the lens 8 hours a day and 5 days a week at least and follow up for one month (30 days). Data will be collected at baseline, 1 week, 2 week and 4 week of daily disposable modality including Adverse Reactions, Slit-lamp findings and Symptoms, Problems, and Complaints, vision acuity, keratometry change and reason for discontinuation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
contact lens material, silicon hydrogel

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Oxysoft
Arm Type
Experimental
Arm Description
olifilcon C, daily disposable soft contact lens, 1 month
Arm Title
SiHy
Arm Type
Active Comparator
Arm Description
olifilcon B, dialy disposable soft contact lens, 1 month
Intervention Type
Device
Intervention Name(s)
oxysoft (olifilcon C)
Intervention Description
subjects meet certain criteria will be administered randomly oxysoft on both eye for one month on daily wear single use modality.
Intervention Type
Device
Intervention Name(s)
Si-Hy (olifilcon B)
Intervention Description
subjects meet certain criteria will be administered randomly Si-Hy on both eye for one month on daily wear single use modality.
Primary Outcome Measure Information:
Title
Log MAR visual acuities
Description
The primary efficacy will be Log MAR visual acuities (VA) of 0.1 or better.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
slit lamp findings
Description
Any slit lamp findings > grade 2 [ Time Frame: over all follow-up visits for the 1 month ] slit lamp findings on 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
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject should have normal eye and use no ocular medications VA correctable to 0.1 LogMAR or better, with spherical lenses ranging in power from -1.00 to -10.00 D myopia, astigmatism =< 2.00 D 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, slip lamp findings greater than grade I (such as cornea or interstitial edema). Subjects have medications that would contraindicate contact lens wear. 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. Any active participation in another clinical trial within 30 days prior to this study. Have had any cornea surgery. Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the next 1 month. Monocular or monovision fits Alcoholic or Drug Abused.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huey Chuan Cheng, MD MSc
Organizational Affiliation
Mackay Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei TzuChi Hopsital, Buddhist Tzu Chi Medical Foundation
City
New Taipei City
ZIP/Postal Code
231
Country
Taiwan
Facility Name
Tri-Service General Hospital_Tingjhou
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
MayKay Memorial Hospital
City
Taipei
ZIP/Postal Code
10449
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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the Clinical Performance of the Oxysoft Daily Disposable Silicone Hydrogel Soft Contact Lens

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