Clinical Assessment of a Multifocal Contact Lens for People Who Use Reading Glasses Only

Not Applicable

Completed

• Conditions: Presbyopia
• Interventions: Device: Lotrafilcon B multifocal contact lens

• Registration Number: NCT01268501
• Lead Sponsor: CIBA VISION

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-29
• Study First Submitted QC: 2010-12-29
• Study First Posted: 2010-12-31
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Results First Submitted: 2012-01-13
• Status Verified: 2012-02
• Results First Submitted QC: 2012-02-06
• Results First Posted: 2012-02-09
• Last Update Submitted: 2012-06-26
• Last Update Posted: 2012-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lotrafilcon B multifocal	Lotrafilcon B multifocal contact lens	Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis

Primary Outcome Measures

Name	Time	Method
Overall Convenience With Contact Lenses	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."