Multifocal Contact Lens Use in Previous Contact Lens Wearers With Near Vision Demands

Not Applicable

Completed

• Conditions: Presbyopia
• Interventions: Device: lotrafilcon B multifocal contact lens; Device: lotrafilcon B single vision contact lens; Other: Over-reader spectacles

• Registration Number: NCT00965237
• Lead Sponsor: CIBA VISION

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-24
• Study First Submitted QC: 2009-08-24
• Study First Posted: 2009-08-25
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Results First Submitted: 2011-01-21
• Results First Submitted QC: 2011-02-17
• Results First Posted: 2011-03-14
• Status Verified: 2012-01
• Last Update Submitted: 2012-06-26
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Multifocal CL / Single vision CL + reading glasses	lotrafilcon B multifocal contact lens	Lotrafilcon B multifocal contact lenses (CL) worn first, with lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis.
Multifocal CL / Single vision CL + reading glasses	lotrafilcon B single vision contact lens	Lotrafilcon B multifocal contact lenses (CL) worn first, with lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis.
Multifocal CL / Single vision CL + reading glasses	Over-reader spectacles	Lotrafilcon B multifocal contact lenses (CL) worn first, with lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis.
Single vision CL + reading glasses / Multifocal CL	lotrafilcon B multifocal contact lens	Lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn first, with lotrafilcon B multifocal contact lenses (CL) worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis.
Single vision CL + reading glasses / Multifocal CL	lotrafilcon B single vision contact lens	Lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn first, with lotrafilcon B multifocal contact lenses (CL) worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis.
Single vision CL + reading glasses / Multifocal CL	Over-reader spectacles	Lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn first, with lotrafilcon B multifocal contact lenses (CL) worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis.

Primary Outcome Measures

Name	Time	Method
Overall Satisfaction With the Lenses	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.

Trial Locations

Locations (1)

University of Waterloo Centre for Contact Lens Research; 🇨🇦 Waterloo, Ontario, Canada