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Comparison of Two Multifocal Contact Lenses Worn on a Daily Disposable Basis

NCT ID: NCT01254760

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

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-01-31

Brief Summary

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The purpose of this trial is to evaluate and compare the clinical performance of two multifocal contact lenses.

Detailed Description

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Conditions

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Presbyopia Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Investigational multifocal / Commercial multifocal

Investigational multifocal contact lenses worn first, with commercial multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.

Group Type OTHER

Nelfilcon A multifocal contact lens, investigational

Intervention Type DEVICE

Investigational, soft, multifocal contact lens for daily wear, daily disposable use.

Nelfilcon A multifocal contact lens, commercial

Intervention Type DEVICE

Commercially marketed, soft, multifocal contact lens FDA-approved for daily wear, daily disposable use.

Commercial multifocal / Investigational multifocal

Commercial multifocal contact lenses worn first, with investigational multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.

Group Type OTHER

Nelfilcon A multifocal contact lens, investigational

Intervention Type DEVICE

Investigational, soft, multifocal contact lens for daily wear, daily disposable use.

Nelfilcon A multifocal contact lens, commercial

Intervention Type DEVICE

Commercially marketed, soft, multifocal contact lens FDA-approved for daily wear, daily disposable use.

Interventions

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Nelfilcon A multifocal contact lens, investigational

Investigational, soft, multifocal contact lens for daily wear, daily disposable use.

Intervention Type DEVICE

Nelfilcon A multifocal contact lens, commercial

Commercially marketed, soft, multifocal contact lens FDA-approved for daily wear, daily disposable use.

Intervention Type DEVICE

Other Intervention Names

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Focus® DAILIES® Progressive

Eligibility Criteria

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Inclusion Criteria

* Age 41 to 68 (inclusive).
* Spectacle add between +0.75 and +2.75D (inclusive).
* Habitual spectacle prescription ≤ 1.00DC (cyl).

Exclusion Criteria

* Eye injury or surgery within twelve weeks of enrollment.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Currently enrolled in a clinical trial.
* Prior refractive surgery.
Minimum Eligible Age

41 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CIBA VISION

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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P-416-C-001 Sub 04

Identifier Type: -

Identifier Source: org_study_id