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
  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:


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
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.

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 July 28, 2014