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

CooperVision, Inc.41 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Astigmatism

Interventions

stenfilcon ADEVICE

contact lens

etafilcon ADEVICE

contact lens

Eligibility

Sex: ALLMin age: 18 YearsMax age: 42 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Kodama Eye Clinic

Terada, Kyoto, Japan

Dougenzaka Ioti Eye Clinic

Shibuya City, Tokyo-to, Japan

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 2 weeks

Data from ClinicalTrials.gov

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