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In Vivo Measurement of Corneal Epithelial Changes in Dry Eye Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01483989
First Posted: December 2, 2011
Last Update Posted: November 18, 2016
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.
Information provided by (Responsible Party):
Alcon Research
November 29, 2011
December 2, 2011
November 18, 2016
February 2011
June 2011   (Final data collection date for primary outcome measure)
Changes in epithelial irregularity following 4 weeks of treatment with a novel artificial tear gel. [ Time Frame: baseline and 28 days ]
The Changes in epithelial irregularity following 4 weeks of treatment with a novel artificial tear gel.
Same as current
Complete list of historical versions of study NCT01483989 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
In Vivo Measurement of Corneal Epithelial Changes in Dry Eye Patients
In Vivo Measurement of Corneal Epithelial Changes in Dry Eye(DE) Patients
The purpose of this study is to measure corneal epithelial changes in dry eye subjects using a novel lubricant eye gel.
The purpose of this study is to measure corneal epithelial changes in dry eye (DE) subjects using a novel lubricant eye gel.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Dry Eye Syndrome
Other: SYSTANE® Gel Drop lubricant eye gel
SYSTANE Gel Drops Lubricant Eye gel dosed (bilaterally) 3 times per day for the 28 day period.
Other Name: Systane Gel
Experimental: SYSTANE® Gel Drops Lubricant eye gel
SYSTANE Gel Drops Lubricant Eye gel dosed (bilaterally) 3 times per day for the 28 day period.
Intervention: Other: SYSTANE® Gel Drop lubricant eye gel
http://iovs.arvojournals.org/article.aspx?articleid=2351788

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
June 2011
June 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Subjects must have history of dry eye as determined by:

  1. Questionnaire
  2. Tear Film Break Up Time less than or equal to 10 seconds
  3. Schirmer's score of less than or equal to 5 mm
  4. Corneal staining greater than or equal to 3 in either eye, and
  5. Positive for conjunctival staining (greater than or equal to 1)

Exclusion Criteria:

  • Patients cannot wear contact lenses within 1 week prior nor during the study, and cannot have a history of hypersensitivity to any component of Systane Gel Drops.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT01483989
SMA-09-49
No
Not Provided
Not Provided
Alcon Research
Alcon Research
Not Provided
Not Provided
Alcon Research
February 2012

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