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Evaluation of Corneal Staining With Various Contact Lens/Solution Combinations

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2007 by Andrasko, Gary, OD, LLC.
Recruitment status was:  Recruiting
Alcon Research
Information provided by:
Andrasko, Gary, OD, LLC Identifier:
First received: September 25, 2006
Last updated: September 26, 2007
Last verified: September 2007
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 Intervention
Corneal Epithelial Disruption Corneal Staining Device: Marketed contact lens care products

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Andrasko, Gary, OD, LLC:

Primary Outcome Measures:
  • Area of Corneal Staining

Secondary Outcome Measures:
  • Type (severity) of Corneal Staining

Estimated Enrollment: 200
Study Start Date: July 2005
Estimated Study Completion Date: March 2008
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information Identifier: NCT00381446     History of Changes
Other Study ID Numbers: MS005
Study First Received: September 25, 2006
Last Updated: September 26, 2007

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

Additional relevant MeSH terms:
Pharmaceutical Solutions processed this record on September 19, 2017