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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00946777
First Posted: July 27, 2009
Last Update Posted: November 18, 2016
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.
Information provided by (Responsible Party):
Alcon Research
  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: 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

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

  Eligibility

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
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

Publications:
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00946777     History of Changes
Other Study ID Numbers: SMA-09-04
First Submitted: July 24, 2009
First Posted: July 27, 2009
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
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases