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

NCT ID: NCT02801006

Last Updated: 2018-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2016-10-31

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.

Conditions

Astigmatism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

stenfilcon A

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

Group Type: EXPERIMENTAL

stenfilcon A

Intervention Type: DEVICE

contact lens

etafilcon A

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

Group Type: ACTIVE_COMPARATOR

etafilcon A

Intervention Type: DEVICE

contact lens

Interventions

stenfilcon A

contact lens

Intervention Type: DEVICE

etafilcon A

contact lens

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuji Kodama, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Director, Kodama Eye Clinic

Locations

Kodama Eye Clinic

Terada, Kyoto, Japan

Dougenzaka Ioti Eye Clinic

Shibuya City, Tokyo-to, Japan

Countries

Japan

Other Identifiers

JP-MKTG-201603

Identifier Type: -

Identifier Source: org_study_id