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

September 25, 2006
September 27, 2006
September 27, 2007
July 2005
Not Provided
Area of Corneal Staining
Same as current
Complete list of historical versions of study NCT00381446 on Archive Site
Type (severity) of Corneal Staining
Same as current
Not Provided
Not Provided
Evaluation of Corneal Staining With Various Contact Lens/Solution Combinations
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.
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.
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
  • Corneal Epithelial Disruption
  • Corneal Staining
Device: Marketed contact lens care products
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
March 2008
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
Not Provided
Andrasko, Gary, OD, LLC
Alcon Research
Principal Investigator: Gary J. Andrasko, OD, MS
Andrasko, Gary, OD, LLC
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP