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Clinical Evaluation of Two Daily Disposable Lenses in Neophytes

NCT ID: NCT00987623

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

326 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 performance of two daily disposable contact lenses in a population of neophytes (new wearers).

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

Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.

Group Type EXPERIMENTAL

nelfilcon A contact lens

Intervention Type DEVICE

Commercially marketed, hydrogel, single-vision contact lens for daily wear, daily disposable use.

narafilcon A

Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.

Group Type ACTIVE_COMPARATOR

narafilcon A contact lens

Intervention Type DEVICE

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

Interventions

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nelfilcon A contact lens

Commercially marketed, hydrogel, single-vision contact lens for daily wear, daily disposable use.

Intervention Type DEVICE

narafilcon A contact lens

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* No previous contact lens experience or attempts to try contact lenses (neophytes).
* Currently wearing spectacles or needing vision correction in both eyes.
* No older than 45 years of age.
* Able to achieve visual acuity of at least 20/40 in each eye with study lenses in the available parameters.
* Interested in wearing contact lenses.
* Willing to wear study lenses for at least 8 hours/day, at least 5 days/week.

Exclusion Criteria

* Eye injury or surgery within twelve weeks prior to enrollment.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Previous corneal or refractive surgery.
* Currently enrolled in any Clinical Trial.
Maximum Eligible Age

45 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

Locations

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The Research Intelligence Group (TRiG)

Fort Washington, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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P-337-C-031

Identifier Type: -

Identifier Source: org_study_id