Clinical Evaluation of Two Daily Disposable Lenses in Neophytes

CIBA VISION1 site in 1 country326 target enrollmentAugust 2009

ConditionsMyopia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Myopia
Sponsor: CIBA VISION
Enrollment: 326
Locations: 1
Primary Endpoint: Overall Lens Satisfaction
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the performance of two daily disposable contact lenses in a population of neophytes (new wearers).

Registry

clinicaltrials.gov

Start Date

August 2009

End Date

December 2009

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

CIBA VISION

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•No previous contact lens experience or attempts to try contact lenses (neophytes).
•Currently wearing spectacles or needing vision correction in both eyes.
•No older than 45 years of age.
•Able to achieve visual acuity of at least 20/40 in each eye with study lenses in the available parameters.
•Interested in wearing contact lenses.
•Willing to wear study lenses for at least 8 hours/day, at least 5 days/week.
•Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria

•Eye injury or surgery within twelve weeks prior to enrollment.
•Pre-existing ocular irritation that would preclude contact lens fitting.
•Previous corneal or refractive surgery.
•Currently enrolled in any Clinical Trial.
•Other protocol-defined inclusion/exclusion criteria may apply.

Outcomes

Primary Outcomes

Overall Lens Satisfaction

Time Frame: 1 week

Overall Lens Satisfaction, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall lens satisfaction was measured on a 10-point scale, with 1 being Poor and 10 being Excellent