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

Astigmatism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02801006
• Other study ID #: JP-MKTG-201603
• Status: Completed
• Phase: N/A
• First received: June 10, 2016
• Last updated: December 11, 2017
• Start date: April 2016
• Est. completion date: October 31, 2016

Study information

• Verified date: December 2017
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 31, 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 42 Years

Eligibility

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.

Related Conditions & MeSH terms

• Astigmatism

Intervention

Device:
• stenfilcon A
contact lens
• etafilcon A
contact lens

Locations

Country	Name	City	State
Japan	Dougenzaka Ioti Eye Clinic	Shibuya	Tokyo-to
Japan	Kodama Eye Clinic	Terada	Kyoto

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 weeks
Primary	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	2 weeks
Primary	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	2 weeks
Primary	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	2 weeks
Primary	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	2 weeks
Primary	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	2 weeks