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Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Lens Wearers

NCT ID: NCT00953407

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

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2009-09-30

Brief Summary

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The purpose of this trial is to evaluate the extent to which symptoms improve in symptomatic contact lens wearers when fit with one of 5 different daily disposable contact lenses.

Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nelfilcon A

Nelfilcon A contact lens

Group Type EXPERIMENTAL

Nelfilcon A contact lens

Intervention Type DEVICE

Daily disposable contact lens worn in a daily wear, daily disposable mode

Narafilcon A

Narafilcon A contact lens

Group Type ACTIVE_COMPARATOR

Narafilcon A contact lens

Intervention Type DEVICE

Daily disposable contact lens worn in a daily wear, daily disposable mode

Etafilcon A

Etafilcon A contact lens

Group Type ACTIVE_COMPARATOR

Etafilcon A contact lens

Intervention Type DEVICE

Daily disposable contact lens worn in a daily wear, daily disposable mode

Omafilcon A

Omafilcon A contact lens

Group Type ACTIVE_COMPARATOR

Omafilcon A contact lens

Intervention Type DEVICE

Daily disposable contact lens worn in a daily wear, daily disposable mode

Hilafilcon B

Hilafilcon B contact lens

Group Type ACTIVE_COMPARATOR

Hilafilcon B contact lens

Intervention Type DEVICE

Daily disposable contact lens worn in a daily wear, daily disposable mode

Interventions

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Nelfilcon A contact lens

Daily disposable contact lens worn in a daily wear, daily disposable mode

Intervention Type DEVICE

Narafilcon A contact lens

Daily disposable contact lens worn in a daily wear, daily disposable mode

Intervention Type DEVICE

Etafilcon A contact lens

Daily disposable contact lens worn in a daily wear, daily disposable mode

Intervention Type DEVICE

Omafilcon A contact lens

Daily disposable contact lens worn in a daily wear, daily disposable mode

Intervention Type DEVICE

Hilafilcon B contact lens

Daily disposable contact lens worn in a daily wear, daily disposable mode

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Currently wear spherical, soft contact lenses replaced at intervals of 2 weeks or monthly.
* Habitually wear lenses for at least 8 hours per day, 4 days per week, for at least the past 6 months.
* Report 2 or more qualifying symptoms with current contact lenses with a frequency of "frequently" or "all the time"
* Able to achieve VA of at least 20/40 in each eye with habitual correction and with study lenses at dispense.

Exclusion Criteria

* Eye injury or surgery within twelve weeks immediately prior to enrollment.
* Currently enrolled in any clinical trial.
* Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
* History of corneal refractive surgery.
* Cylinder correction greater than 1.00 D.
* Current monovision contact lens wearers.
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

Countries

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United States

Other Identifiers

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P-337-C-027

Identifier Type: -

Identifier Source: org_study_id