Clinical Assessment of a New Multifocal Contact Lens With Emmetropic Presbyopes

CIBA VISION0 sites103 target enrollmentDecember 2010

ConditionsPresbyopia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Presbyopia
Sponsor: CIBA VISION
Enrollment: 103
Primary Endpoint: Overall Convenience With Contact Lenses
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The purpose of this trial is to evaluate the use of multifocal contact lenses in people who use reading glasses only.

Registry

clinicaltrials.gov

Start Date

December 2010

End Date

February 2011

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

•Is between 40 and 48 years of age (inclusive).
•Has read and signed the Informed Consent.
•Is willing and able to follow instructions and maintain the appointment schedule.
•Wears reading spectacles for close work.
•Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria

•Eye injury or surgery within twelve weeks of enrollment.
•Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of accessory solutions.
•Currently enrolled in a clinical trial.
•Has worn contact lenses previously.
•Other protocol-defined inclusion/exclusion criteria may apply.

Outcomes

Primary Outcomes

Overall Convenience With Contact Lenses

Time Frame: 3 weeks of wear

Overall convenience with contact lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 3 weeks of wear time. Overall convenience is measured on a 4-point scale: 1=very satisfied; 2=satisfied; 3=dissatisfied; 4=very dissatisfied. Results were reported as a percentage of participants who responded, "very satisfied" or "satisfied."