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

Clinical Assessment of a New Multifocal Contact Lens With Emmetropic Presbyopes

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

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Device: Lotrafilcon B multifocal contact lens

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 48 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Lotrafilcon B multifocal; Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis	Device: Lotrafilcon B multifocal contact lens; Commercially marketed, silicone hydrogel, multifocal, soft contact lenses FDA-approved for up to 4 weeks recommended replacement schedule and up to 6 nights of extended (overnight) wear.; Other Names: AIR OPTIX® AQUA MULTIFOCAL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Convenience With Contact Lenses	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."	3 weeks of wear

Collaborators and Investigators

• Sponsor: CIBA VISION

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (ACTUAL): February 1, 2011
• Study Completion (ACTUAL): February 1, 2011

Study Registration Dates

• First Submitted: December 29, 2010
• First Submitted That Met QC Criteria: December 29, 2010
• First Posted (ESTIMATE): December 31, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): June 29, 2012
• Last Update Submitted That Met QC Criteria: June 26, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: P-319-C-019