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

This study has been completed.
Information provided by (Responsible Party):
Alcon Research Identifier:
First received: July 24, 2009
Last updated: November 17, 2016
Last verified: February 2012
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: 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:

Further study details as provided by Alcon Research:

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

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

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


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.
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

Responsible Party: Alcon Research Identifier: NCT00946777     History of Changes
Other Study ID Numbers: SMA-09-04
Study First Received: July 24, 2009
Last Updated: November 17, 2016

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 processed this record on April 26, 2017