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

Primary Purpose

Myopia

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

OxyAqua

Si-Hy

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

Subjects should have normal eyes and use no ocular medications. They may have worn contact lenses previously, provided their eyes are shown to be normal at the start of the investigation. A normal eye is defined as having the following characteristics:
1. No anterior segment infection, inflammation or abnormality.
2. No other active ocular or systemic disease that would contraindicate contact lens wear; and
3. No medications that would contraindicate contact lens wear.
VA correctable to 0.1 LogMAR or better, with spherical lenses ranging in power from
1.00 to -10.00 D myopia, astigmatism less than 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:

Have history of allergies that would contraindicate "normal" contact lens wear.
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).
Have medications that would contraindicate contact lens wear.
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.
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.
No monocular or monovision fits.
Alcoholic or Drug Abused.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

OxyAqua

Si-Hy

Arm Description

OxyAqua (olifilcon D) daily disposable

Si-Hy (olifilcon B) daily disposable

Outcomes

Primary Outcome Measures

Log MAR visual acuity (VA)

the visual acuity corrected with contact lens could reach 0.1 or better

Secondary Outcome Measures

Any slit lamp findings > grade 2

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.

Subjective response to comfort, symptoms and complaints

subjective ratings of comfort, symptom and complaints using a scale of 0=severe stinging/Burning to 5=No stinging/Burning for each eye

Full Information

NCT ID

NCT03139201

First Posted

April 29, 2017

Last Updated

May 2, 2017

Sponsor

Visco Vision Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03139201

Brief Title

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

Official Title

A Prospective Randomized Controlled Study to Evaluate the Clinical Performance of OxyAqua Silicone Hydrogel Soft Contact Lens

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

September 21, 2016 (Actual)

Primary Completion Date

December 8, 2016 (Actual)

Study Completion Date

December 8, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Visco Vision Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

The objective of this study is to demonstrate that the OxyAqua 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 from one hospital. 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

silicone hydrogel 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

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

OxyAqua

Arm Type

Experimental

Arm Description

OxyAqua (olifilcon D) daily disposable

Arm Title

Si-Hy

Arm Type

Active Comparator

Arm Description

Si-Hy (olifilcon B) daily disposable

Intervention Type

Device

Intervention Name(s)

OxyAqua

Intervention Description

OxyAqua (olifilcon D) silicone hydrogel soft contact lens

Intervention Type

Device

Intervention Name(s)

Si-Hy

Intervention Description

Si-Hy (oliflcon B) silicone hydrogel soft contact lens

Primary Outcome Measure Information:

Title

Log MAR visual acuity (VA)

Description

the visual acuity corrected with contact lens could reach 0.1 or better

Time Frame

one month

Secondary Outcome Measure Information:

Title

Any slit lamp findings > grade 2

Description

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

over all follow-up visits for the 1 month

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 5=No stinging/Burning for each eye

Time Frame

over all follow-up visits for the 1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects should have normal eyes and use no ocular medications. They may have worn contact lenses previously, provided their eyes are shown to be normal at the start of the investigation. A normal eye is defined as having the following characteristics: No anterior segment infection, inflammation or abnormality. No other active ocular or systemic disease that would contraindicate contact lens wear; and No medications that would contraindicate contact lens wear. VA correctable to 0.1 LogMAR or better, with spherical lenses ranging in power from 1.00 to -10.00 D myopia, astigmatism less than 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: Have history of allergies that would contraindicate "normal" contact lens wear. 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). Have medications that would contraindicate contact lens wear. 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. 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. No monocular or monovision fits. Alcoholic or Drug Abused.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Huey Chuan Cheng, MD MDS

Organizational Affiliation

Mackay Memorial Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Shu-I Yeh, MD MS

Organizational Affiliation

MacKay Memorial Hospital - Tamshui

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jy Been Liang, MD

Organizational Affiliation

Tri-Service General Hopsital - Tingjhou Branch

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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