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The Clinical Study of Silicone Hydrogel Daily Disposable Stenfilcon A Toric Lens

Primary Purpose

Astigmatism

Status

Completed

Phase

Not Applicable

Locations

Japan

Study Type

Interventional

Intervention

stenfilcon A

etafilcon A

About this trial

This is an interventional treatment trial for Astigmatism

Eligibility Criteria

18 Years - 42 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

Is between 18 years of age and 42 years of age.
Soft contact lens wearers who are not required to have Presbyopic correction.
Soft contact lens wearers without trouble.
Soft contact lens wearers who have the correctable astigmatism by lenses used in this study in the both eyes.
Has a prescribed SCL (Soft Contact Lens) power within the range of powers of the SCL for astigmatism which is used in this study.
Can achieve a corrected visual acuity of 1.0 or better.
Can read and understand the study information document, and sign the participation consent form.
Can visit the clinic at designated examination visits.
Has received periodical examinations at an eye clinic within the past two years.

Exclusion Criteria:

A person will be excluded from the study if he/she:

Has a systemic disease that may affect the ocular health.
Is pregnant or lactating.
Has received a systemic or local medication that may affect this study.
Has an infectious eye disease.
Has eye and systemic active allergic diseases that interferes with SCL wear.
Has an eye disease which is clinically judged to be severe such as corneal vascularization, limbal hyperemia, and corneal epithelium disorder
Has a history of hard contact lens wear within 30 days.
Is currently participating in another clinical research study.
Has undergone refractive surgery.

Sites / Locations

Kodama Eye Clinic
Dougenzaka Ioti Eye Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

stenfilcon A

etafilcon A

Arm Description

Participants will be randomized to wear stenfilcon A lens pair for two weeks during the cross over study.

Participants will be randomized to wear etafilcon A lens pair for two weeks during the cross over study.

Outcomes

Primary Outcome Measures

Comfort

Wearing comfort (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0= extremely uncomfortable cannot wear at all, 10=very comfortable and feel no lens at all

Dryness

Dryness (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=extremely dried and cannot wear lens, 10=feel no dryness at all

Clarity of Vision

Clarity of vision (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=blur vision and cannot see at all, 10=very clear with no blur vision at all

Stability of Vision

Stability of vision (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=unstable vision and cannot see at all, 10=always stable vision

Lens Handling

Lens handling for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=cannot handle at all, 10=no problem at all

Overall Satisfaction

Overall satisfaction for stenfilcon A and etafilcon A toric lens pair is assessed. scale 0-10, 0=extremely un-satisfy, 10=very satisfy

Secondary Outcome Measures

Full Information

NCT ID

NCT02801006

First Posted

June 10, 2016

Last Updated

December 11, 2017

Sponsor

Coopervision, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02801006

Brief Title

The Clinical Study of Silicone Hydrogel Daily Disposable Stenfilcon A Toric Lens

Official Title

The Clinical Study of Silicone Hydrogel Daily Disposable Stenfilcon A Toric Lens

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Completed

Study Start Date

April 2016 (undefined)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

October 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Coopervision, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of this study is to evaluate the clinical performance of stenfilcon A toric lenses compared with etafilcon A toric lenses for astigmatism. If it is valuable, the clinical performance of stenfilcon A toric lens is also evaluated compared with habitual lenses.

Detailed Description

This is a multi-sites, 50 subjects, randomized, open labeled, bilateral wear, dispensing study. Participants will be randomized to wear first lens pair for two weeks, and then crossover to second lens pair for two weeks.

6. Conditions and Keywords

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

Astigmatism

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

stenfilcon A

Arm Type

Experimental

Arm Description

Participants will be randomized to wear stenfilcon A lens pair for two weeks during the cross over study.

Arm Title

etafilcon A

Arm Type

Active Comparator

Arm Description

Participants will be randomized to wear etafilcon A lens pair for two weeks during the cross over study.

Intervention Type

Device

Intervention Name(s)

stenfilcon A

Intervention Description

contact lens

Intervention Type

Device

Intervention Name(s)

etafilcon A

Intervention Description

contact lens

Primary Outcome Measure Information:

Title

Comfort

Description

Time Frame

2 weeks

Title

Dryness

Description

Dryness (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=extremely dried and cannot wear lens, 10=feel no dryness at all

Time Frame

2 weeks

Title

Clarity of Vision

Description

Clarity of vision (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=blur vision and cannot see at all, 10=very clear with no blur vision at all

Time Frame

2 weeks

Title

Stability of Vision

Description

Stability of vision (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=unstable vision and cannot see at all, 10=always stable vision

Time Frame

2 weeks

Title

Lens Handling

Description

Lens handling for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=cannot handle at all, 10=no problem at all

Time Frame

2 weeks

Title

Overall Satisfaction

Description

Overall satisfaction for stenfilcon A and etafilcon A toric lens pair is assessed. scale 0-10, 0=extremely un-satisfy, 10=very satisfy

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

42 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: A person is eligible for inclusion in the study if he/she: Is between 18 years of age and 42 years of age. Soft contact lens wearers who are not required to have Presbyopic correction. Soft contact lens wearers without trouble. Soft contact lens wearers who have the correctable astigmatism by lenses used in this study in the both eyes. Has a prescribed SCL (Soft Contact Lens) power within the range of powers of the SCL for astigmatism which is used in this study. Can achieve a corrected visual acuity of 1.0 or better. Can read and understand the study information document, and sign the participation consent form. Can visit the clinic at designated examination visits. Has received periodical examinations at an eye clinic within the past two years. Exclusion Criteria: A person will be excluded from the study if he/she: Has a systemic disease that may affect the ocular health. Is pregnant or lactating. Has received a systemic or local medication that may affect this study. Has an infectious eye disease. Has eye and systemic active allergic diseases that interferes with SCL wear. Has an eye disease which is clinically judged to be severe such as corneal vascularization, limbal hyperemia, and corneal epithelium disorder Has a history of hard contact lens wear within 30 days. Is currently participating in another clinical research study. Has undergone refractive surgery.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yuji Kodama, MD, PhD

Organizational Affiliation

Director, Kodama Eye Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kodama Eye Clinic

City

Terada

State/Province

Kyoto

ZIP/Postal Code

610-0121

Country

Japan

Facility Name

Dougenzaka Ioti Eye Clinic

City

Shibuya

State/Province

Tokyo-to

ZIP/Postal Code

150-0043

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

The Clinical Study of Silicone Hydrogel Daily Disposable Stenfilcon A Toric Lens

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