Clinical Trial of Several Contact Lenses in Extended Wear

Johnson & Johnson Vision Care, Inc.1 site in 1 country350 target enrollmentFebruary 2007

ConditionsMyopia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Myopia
Sponsor: Johnson & Johnson Vision Care, Inc.
Enrollment: 350
Locations: 1
Primary Endpoint: Incidence of Corneal Infiltrative Events
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study is to clinically evaluate currently marketed contact lenses when used in an extended wear modality of up to seven days/six nights.

Registry

clinicaltrials.gov

Start Date

February 2007

End Date

September 2009

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Johnson & Johnson Vision Care, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Be of legal age, and be between 18 and 39 years of age.
•Signed Written Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.
•Require a visual correction in both eyes (Monovision not allowed)
•Require a soft contact lens spherical correction between -0.50 and -9.00D.
•Have an astigmatic correction less than 1.50D in both eyes.
•Be able to wear the lens powers available for this study.
•Be able to regularly wear the lenses on a 7 day/6 night extended wear basis (e.g. does not regularly swim more than once a week)
•Be correctable to a visual acuity of 20/30 or better in each eye.
•Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
•No amblyopia.

Exclusion Criteria

•Requires concurrent ocular medication.
•Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
•No Clinically significant (Grade 3 or 4) slit lamp findings including corneal edema, corneal vascularization, corneal staining, tarsal abnormalities, bulbar injection, or any other abnormality of the cornea that would contraindicate contact lens wear.
•Diabetic.
•Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
•PMMA or RGP lens wear in the previous 8 weeks.
•Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrolment for this study.
•Abnormal lacrimal secretions.
•Pre-existing ocular irritation that would preclude contact lens fitting.
•Keratoconus or other corneal irregularity.

Outcomes

Primary Outcomes

Incidence of Corneal Infiltrative Events

Time Frame: 52 weeks

Extended wear is defined as 7 days, 6 nights of lens wear, weekly replacement of lenses. Incidence was calculated as the number of subjects with event divided by the total number of subjects assigned to that lens type.

Incidence of Adverse Events

Time Frame: 52 weeks

Occurrence of any Adverse Event by study lens. Incidence was calculated as the number of subjects with event divided by the total number of subjects assigned to that lens type.