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

NCT ID: NCT00965237

Last Updated: 2012-07-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2009-12-31

Brief Summary

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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

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Conditions

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Presbyopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Multifocal CL / Single vision CL + reading glasses

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.

Group Type OTHER

lotrafilcon B multifocal contact lens

Intervention Type DEVICE

Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use

lotrafilcon B single vision contact lens

Intervention Type DEVICE

Commercially marketed, silicone hydrogel, single vision contact lens for daily wear use

Over-reader spectacles

Intervention Type OTHER

Reading glasses worn over single vision contact lenses for near vision work on an as-needed basis

Single vision CL + reading glasses / Multifocal CL

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.

Group Type OTHER

lotrafilcon B multifocal contact lens

Intervention Type DEVICE

Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use

lotrafilcon B single vision contact lens

Intervention Type DEVICE

Commercially marketed, silicone hydrogel, single vision contact lens for daily wear use

Over-reader spectacles

Intervention Type OTHER

Reading glasses worn over single vision contact lenses for near vision work on an as-needed basis

Interventions

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lotrafilcon B multifocal contact lens

Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use

Intervention Type DEVICE

lotrafilcon B single vision contact lens

Commercially marketed, silicone hydrogel, single vision contact lens for daily wear use

Intervention Type DEVICE

Over-reader spectacles

Reading glasses worn over single vision contact lenses for near vision work on an as-needed basis

Intervention Type OTHER

Eligibility Criteria

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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

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Waterloo

OTHER

Sponsor Role collaborator

CIBA VISION

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Waterloo Centre for Contact Lens Research

Waterloo, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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P-368-C-101

Identifier Type: -

Identifier Source: org_study_id