Clinical Evaluation of Two Daily Disposable Contact Lenses

Johnson & Johnson Vision Care, Inc.0 sites50 target enrollmentSeptember 2007

ConditionsRefractive Error

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Refractive Error
Sponsor: Johnson & Johnson Vision Care, Inc.
Enrollment: 50
Primary Endpoint: Lens Comfort
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This study seeks to evaluate the clinical performance of two daily disposable contact lenses.

Registry

clinicaltrials.gov

Start Date

September 2007

End Date

September 2007

Last Updated

7 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Johnson & Johnson Vision Care, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Be between 21 and 39 years of age.
•Signed Written Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.
•Be existing (i.e. successfully worn for 1-month prior to the study) soft contact lens wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed).
•Require a visual correction in both eyes (monovision allowed but no monofit).
•Have a contact lens spherical distance requirement between -1.00D and -6.00D in both eyes.
•Astigmatism of 1.00D or less in both eyes.
•Be able to wear the lens powers available for this study.
•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.
•Clinically significant (Grade 3 or 4) corneal edema, corneal vascularisation, 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).
•Extended lens wear in last 3 months.
•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 enrollment for this study.
•Abnormal lacrimal secretions.
•Pre-existing ocular irritation that would preclude contact lens fitting.

Outcomes

Primary Outcomes

Lens Comfort

Time Frame: 1-week follow-up

Lens comfort was evaluated via the subjective question: "How comfortable did your eyes feel at the end of the day when wearing the contact lenses you were provided?" (excellent/very good=5...very good=3...Poor=0)