Assessing the Performance of Lotrafilcon A Lenses During a Three Month Period

CIBA VISION0 sites169 target enrollmentJune 2009

ConditionsMyopia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Myopia
Sponsor: CIBA VISION
Enrollment: 169
Primary Endpoint: Comfort After Insertion
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The purpose of this trial is to assess the performance of an investigational contact lens over a three month period.

Registry

clinicaltrials.gov

Start Date

June 2009

End Date

November 2009

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

CIBA VISION

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•On examination, have ocular findings considered to be "normal," and which would not prevent a participant from safely wearing contact lenses.
•Be willing and able to follow instructions and meet the schedule of follow-up visits as defined in the informed consent.
•Be able to wear the study lenses in the available powers.
•Currently wear contact lenses for a minimum of 5 days a week, and at least 8 hours a day.
•Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria

•Eye injury or surgery within twelve weeks of enrollment.
•Pre-existing ocular irritation that would preclude contact lens fitting.
•Currently enrolled in an ophthalmic clinical trial.
•Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
•History of corneal refractive surgery.
•Other protocol-defined inclusion/exclusion criteria may apply.

Outcomes

Primary Outcomes

Comfort After Insertion

Time Frame: 3 months

Comfort after insertion (30 seconds to 1 minute) as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of three months' wear time. Comfort after insertion was measured on a 10-point scale, with 1 being poor and 10 being excellent.