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Evaluation of Corneal Staining With Various Contact Lens/Solution Combinations

NCT ID: NCT00381446

Last Updated: 2007-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2008-03-31

Brief Summary

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The purpose of this study is to quantify the amount of corneal staining observed with various marketed contact lens/multipurpose solution combinations. The hypothesis is that there are measurable differences in the amount of corneal staining between the various combinations.

Detailed Description

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A series of clinical studies is being conducted at one research site using a double-masked, randomized cross-over design. Each study consists of asymptomatic daily wear soft contact lens wearers observed at baseline and at two and four hours post lens insertion. Corneal staining is being assessed using sodium fluorescein, a cobalt filter and a yellow filter. Subjective comfort assessments are obtained at each visit.

Conditions

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Corneal Epithelial Disruption Corneal Staining

Keywords

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corneal staining contact lens care multipurpose solution

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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Marketed contact lens care products

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* currently wearing soft contact lenses daily wear for at least 2 weeks prior to study
* correct visual acuity of 20/30 or better each eye

Exclusion Criteria

* history of hypersensitivity to any components of solution being tested
* any ocular condition prohibiting contact lens wear
* excessive baseline staining as defined in protocol
* use of topical or OTC ocular medications during the study
* seasonal allergies with significant effect on contact lens wear
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role collaborator

Andrasko, Gary, OD, LLC

INDIV

Sponsor Role lead

Principal Investigators

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Gary J. Andrasko, OD, MS

Role: PRINCIPAL_INVESTIGATOR

Locations

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Dr. Richard Erdey office

Columbus, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Gary J. Andrasko, OD, MS

Role: CONTACT

Phone: 614-459-3363

Email: [email protected]

Facility Contacts

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Gary J. Andrasko, OD, MS

Role: primary

Other Identifiers

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MS005

Identifier Type: -

Identifier Source: org_study_id