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

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. Identifier: NCT00946777
Recruitment Status : Completed
First Posted : July 27, 2009
Last Update Posted : November 18, 2016
Information provided by (Responsible Party):
Alcon Research

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

Condition or disease Intervention/treatment Phase
Dry Eye Other: Systane® Ultra Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Barrier Function Measurement in Dry Eye Patients After Using Systane Ultra for 30 Days
Study Start Date : July 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Systane
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Systane® Ultra Other: Systane® Ultra
Systane® Ultra 1-2 drops, 4 times per day for 30 days

Primary Outcome Measures :
  1. Percent change from baseline of corneal fluorescein [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Adverse event occurence [ Time Frame: 30 Days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Publications of Results:
Responsible Party: Alcon Research Identifier: NCT00946777     History of Changes
Other Study ID Numbers: SMA-09-04
First Posted: July 27, 2009    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: February 2012

Keywords provided by Alcon Research:
Dry Eye Signs
barrier function

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