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

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ClinicalTrials.gov Identifier: NCT00946777
Recruitment Status : Completed
First Posted : July 27, 2009
Last Update Posted : November 18, 2016
Sponsor:
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
Dry Eye Other: Systane® Ultra

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
Primary Completion Date : September 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
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
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.

Publications:
Responsible Party: Alcon Research
ClinicalTrials.gov 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
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases