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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00938951

First Posted: July 14, 2009

Last Update Posted: February 9, 2012

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 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	Intervention
Dry Eye Symptoms Visual Performance	Other: Systane® Ultra


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Supportive Care

Resource links provided by NLM:

Drug Information available for: Systane

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

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 ]


Enrollment:	16
Study Start Date:	June 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Systane® Ultra Systane® Ultra	Other: Systane® Ultra Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%

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:	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

No Contacts or Locations Provided

More Information


Responsible Party:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00938951 History of Changes
Other Study ID Numbers:	SMA-09-22
First Submitted:	July 13, 2009
First Posted:	July 14, 2009
Last Update Posted:	February 9, 2012
Last Verified:	February 2012

Keywords provided by Alcon Research:


Dry Eye Visual Performance

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