Evaluation of Corneal Staining With Various Contact Lens/Solution Combinations

September 26, 2007 updated by: Andrasko, Gary, OD, LLC

Evaluation of Corneal Staining With Market Contact Lens/Solution Combinations

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43213
        • Recruiting
        • Dr. Richard Erdey office
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Area of Corneal Staining

Secondary Outcome Measures

Outcome Measure
Type (severity) of Corneal Staining

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andrasko, Gary, OD, LLC

Collaborators

Alcon Research

Investigators

  • Principal Investigator: Gary J. Andrasko, OD, MS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Study Completion (Anticipated)

March 1, 2008

Study Registration Dates

First Submitted

September 25, 2006

First Submitted That Met QC Criteria

September 25, 2006

First Posted (Estimate)

September 27, 2006

Study Record Updates

Last Update Posted (Estimate)

September 27, 2007

Last Update Submitted That Met QC Criteria

September 26, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MS005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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