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

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.

Study Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Device: stenfilcon A; Device: etafilcon A

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Kyoto
    • Terada, Kyoto, Japan, 610-0121
      • Kodama Eye Clinic
  • Tokyo-to
    • Shibuya, Tokyo-to, Japan, 150-0043
      • Dougenzaka Ioti Eye Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 42 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: stenfilcon A; Participants will be randomized to wear stenfilcon A lens pair for two weeks during the cross over study.	Device: stenfilcon A; contact lens
Active Comparator: etafilcon A; Participants will be randomized to wear etafilcon A lens pair for two weeks during the cross over study.	Device: etafilcon A; contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Yuji Kodama, MD, PhD, Director, Kodama Eye Clinic

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): October 31, 2016

Study Registration Dates

• First Submitted: June 10, 2016
• First Submitted That Met QC Criteria: June 10, 2016
• First Posted (Estimate): June 15, 2016

Study Record Updates

• Last Update Posted (Actual): January 9, 2018
• Last Update Submitted That Met QC Criteria: December 11, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: JP-MKTG-201603

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes