The Clinical Performance of the Silicone Hydrogel Contact Lens on Low to Moderate Astigmatism in Japan

Johnson & Johnson Vision Care, Inc.10 sites in 1 country102 target enrollmentFebruary 2008

ConditionsRefractive Error Myopia Astigmatism

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Refractive Error
Sponsor: Johnson & Johnson Vision Care, Inc.
Enrollment: 102
Locations: 10
Primary Endpoint: Subject-reported satisfaction for vision
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study seeks to evaluate the clinical performance of a recently released contact lens designed to correct astigmatism to an established contact lens that has historically been used in these patients.

Registry

clinicaltrials.gov

Start Date

February 2008

End Date

June 2008

Last Updated

11 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Johnson & Johnson Vision Care, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The subject is 18 to 39 years of age. (Parental consent is required for a minor child i.e. under the age of 20.)
•The subject has signed an informed consent with his/her own judgement for participation in the study.
•The subject currently is a habitual wearer of spherical or toric daily-wear soft contact lenses, excluding daily disposables, in daily wear bases.

Exclusion Criteria

•The subject has any ocular or systemic allergies that interfere with contact lens wear.
•The subject has dry eye and lacrimal apparatus disease that could interfere with contact lens wear.
•The subject has any systemic disease or autoimmune disease that interferes with contact lens wear.
•The subject has corneal edema, neovascularization, corneal staining or other ocular abnormalities (Grade 3 or above) that clinically apparently interfere with contact lens wear.
•The subject has any anterior segment eye disease (palpebral abnormalities, corneal hypesthesia, corneal epithelial defect, bulbar conjunctival hyperemia, etc.) that clinically apparently interferes with contact lens wear.
•The subject has a history of solution reactions to the chemical cleaner/disinfectant to be used in this study, as far as known to the subject.
•The subject has ocular infection.
•The subject has ocular inflammation (including acute/subacute anterior segment inflammations and uveitis).
•The subject has corneal distortion resulting from previous experience of hard contact lens wear.
•The subject has infectious disease (pneumonia, tuberculosis, etc.) or immunosuppressive disease (HIV positive etc.), as far as known to the subject.