P/331/09/C: Multifocal Pilot Study: Refitting Drop Outs (GARM)

CIBA VISION1 site in 1 country16 target enrollmentAugust 2009

ConditionsPresbyopia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Presbyopia
Sponsor: CIBA VISION
Enrollment: 16
Locations: 1
Primary Endpoint: Overall Satisfaction With the Lenses
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 use of a multifocal contact lens in people who previously wore contact lenses but discontinued due to age-related, near vision demands.

Registry

clinicaltrials.gov

Start Date

August 2009

End Date

December 2009

Last Updated

13 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

CIBA VISION

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•has discontinued contact lens wear primarily due to age-related, near vision demands
•requires a reading add of +0.50 to +1.75 D (inclusive) and is correctable to at least 6/9 monocular, distance and near with spectacle correction
•has had an ocular examination in the last 2 years
•Other protocol-defined inclusion/exclusion criteria may apply

Exclusion Criteria

•has any ocular disease
•has more than a 2.00D prescription difference between eyes
•cannot be fit successfully with the study contact lenses
•has any systemic disease affecting ocular health
•is using any systemic or topical medications that may affect ocular health
•has undergone corneal refractive surgery
•Other protocol-defined inclusion/exclusion criteria may apply

Outcomes

Primary Outcomes

Overall Satisfaction With the Lenses

Time Frame: 1 week of wear

Overall satisfaction with the lenses was interpreted by and assessed by the subject as a single, retrospective measurement of one week's wear time. Overall satisfaction with the lenses was recorded on a questionnaire as a numerical rating on a scale of 1 to 100, with 1 being completely dissatisfied, and 100 being excellent, completely satisfied.