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Barrier Function Measurement in Dry Eye Patients After Using Systane Ultra for 30 Days

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00946777
First received: July 24, 2009
Last updated: February 8, 2012
Last verified: February 2012
History of Changes
  Purpose

The primary objective is to determine if there is a correlation between reductions in corneal staining and improvements in corneal barrier function.


Condition Intervention
Dry Eye
 Other: Systane® Ultra

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Barrier Function Measurement in Dry Eye Patients After Using Systane Ultra for 30 Days

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Percent change from baseline of corneal fluorescein [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse event occurence [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]

Enrollment: 19
Study Start Date: July 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Systane® Ultra Other: Systane® Ultra
Systane® Ultra 1-2 drops, 4 times per day for 30 days

  Eligibility

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

Inclusion Criteria:

  • Patients must have moderate corneal staining and exhibit a need to use artificial tears.

Exclusion Criteria:

  • Patients can not participate in any other ophthalmic drug or device clinical trial within 30 days of the baseline visit.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00946777     History of Changes
Other Study ID Numbers: SMA-09-04
Study First Received: July 24, 2009
Last Updated: February 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Dry Eye Signs
barrier function

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

ClinicalTrials.gov processed this record on May 16, 2013