Corneal Barrier Function With Multi-Purpose Solutions

Sponsor
Southern California College of Optometry at Marshall B. Ketchum University (Other)
Overall Status
Completed
CT.gov ID
NCT00407238
Collaborator
Alcon Research (Industry)
25
1
3.9
6.3

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effect on epithelial barrier function of three emarketed multi-purpose solution applied to the human eye with hydrogel lenses as during normal regimen use.

Condition or Disease Intervention/Treatment Phase
  • Device: Multi-purpose solutions (polyquaternium-1 and PHMB)
N/A

Detailed Description

The purpose of this study is to evaluate the effect on epithelial barrier function of three emarketed multi-purpose solution applied to the human eye with hydrogel lenses as during normal regimen use.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
Comparison of Human Corneal Barrier Function With Three Marketed Multi-Purpose Solutions
Study Start Date :
Nov 1, 2006
Actual Study Completion Date :
Mar 1, 2007

Outcome Measures

Primary Outcome Measures

  1. Ratio of fluorescein dye penetration rate of test eye vs. control []

Secondary Outcome Measures

  1. Corneal fluorescein staining []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Adapted daily soft contact lens wearers, at least 18 years of age, vision correctable to 20/40
Exclusion Criteria:
  • Ocular or systemic allergies, abnormalities of the cornea, active ocular infection, prior keratorefractive surgery, use of ocular medications

Contacts and Locations

Locations

Site City State Country Postal Code
1 Southern California College of Optometry Fullerton California United States 92831

Sponsors and Collaborators

  • Southern California College of Optometry at Marshall B. Ketchum University
  • Alcon Research

Investigators

  • Principal Investigator: Jerry R Paugh, OD, PhD, Southern California College of Optometry at Marshall B. Ketchum University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00407238
Other Study ID Numbers:
  • 6-08
First Posted:
Dec 4, 2006
Last Update Posted:
Oct 23, 2007
Last Verified:
Oct 1, 2007

Study Results

No Results Posted as of Oct 23, 2007