Text Size

In Vivo Measurement of Corneal Epithelial Changes in Dry Eye Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01483989
First received: November 29, 2011
Last updated: February 8, 2012
Last verified: February 2012
History of Changes
  Purpose

The purpose of this study is to measure corneal epithelial changes in dry eye subjects using a novel lubricant eye gel.


Condition Intervention
Dry Eye Syndrome
 Other: SYSTANE® Gel Drop lubricant eye gel

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: In Vivo Measurement of Corneal Epithelial Changes in Dry Eye(DE) Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Changes in epithelial irregularity following 4 weeks of treatment with a novel artificial tear gel. [ Time Frame: baseline and 28 days ] [ Designated as safety issue: No ]
    The Changes in epithelial irregularity following 4 weeks of treatment with a novel artificial tear gel.


Enrollment: 19
Study Start Date: February 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SYSTANE® Gel Drops Lubricant eye gel
SYSTANE Gel Drops Lubricant Eye gel dosed (bilaterally) 3 times per day for the 28 day period.
 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

Detailed Description:

The purpose of this study is to measure corneal epithelial changes in dry eye (DE) subjects using a novel lubricant eye gel.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01483989     History of Changes
Other Study ID Numbers: SMA-09-49
Study First Received: November 29, 2011
Last Updated: February 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Dry Eye
Epithelial changes

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
 Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases

ClinicalTrials.gov processed this record on May 16, 2013