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Evaluate the Ability of Systane Ultra to Improve Subjective Symptoms of Ocular Irritation Post 60 Min. Athletic Performance.

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ClinicalTrials.gov Identifier: NCT00938951
Recruitment Status : Completed
First Posted : July 14, 2009
Last Update Posted : February 9, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The primary objective of this study is to compare visual degradation in a stressed (forced stare) environment in patients before and after acute administration of Systane Ultra.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Study Start Date : June 2009
Actual Primary Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
Drug Information available for: Systane
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Systane® Ultra
Systane® Ultra
 Other: Systane® Ultra
Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%


Outcome Measures
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Primary Outcome Measures :
  1. Effectiveness of eye drop basd on athlete's opinion/experience during a one hour practice session [ Time Frame: 60 minutes post-dosing with test article ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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:   Yes
Criteria

Inclusion Criteria:

  • Player/ Coach must answer "Yes" to the survey eligibility question.
  • Player/Coach must voluntarily agree to participate in survey

Exclusion Criteria:

Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00938951     History of Changes
Other Study ID Numbers: SMA-09-22
First Posted: July 14, 2009    Key Record Dates
Last Update Posted: February 9, 2012
Last Verified: February 2012

Keywords provided by Alcon Research:
Dry Eye
Visual Performance