Evaluation of Corneal Staining With Various Contact Lens/Solution Combinations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00381446
Recruitment Status : Unknown
Verified September 2007 by Andrasko, Gary, OD, LLC.
Recruitment status was:  Recruiting
First Posted : September 27, 2006
Last Update Posted : September 27, 2007
Alcon Research
Information provided by:
Andrasko, Gary, OD, LLC

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Corneal Epithelial Disruption Corneal Staining Device: Marketed contact lens care products Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Evaluation of Corneal Staining With Market Contact Lens/Solution Combinations
Study Start Date : July 2005
Estimated Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Primary Outcome Measures :
  1. Area of Corneal Staining

Secondary Outcome Measures :
  1. Type (severity) of Corneal Staining

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00381446

Contact: Gary J. Andrasko, OD, MS 614-459-3363

United States, Ohio
Dr. Richard Erdey office Recruiting
Columbus, Ohio, United States, 43213
Contact: Gary J. Andrasko, OD, MS    614-459-3363   
Sponsors and Collaborators
Andrasko, Gary, OD, LLC
Alcon Research
Principal Investigator: Gary J. Andrasko, OD, MS Identifier: NCT00381446     History of Changes
Other Study ID Numbers: MS005
First Posted: September 27, 2006    Key Record Dates
Last Update Posted: September 27, 2007
Last Verified: September 2007

Keywords provided by Andrasko, Gary, OD, LLC:
corneal staining
contact lens care
multipurpose solution

Additional relevant MeSH terms:
Pharmaceutical Solutions