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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research

ClinicalTrials.gov Identifier:

NCT00938951

First received: July 13, 2009

Last updated: February 8, 2012

Last verified: February 2012

History of Changes

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: 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 ] [ Designated as safety issue: No ]


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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Study First Received:	July 13, 2009
Last Updated:	February 8, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Alcon Research:


Dry Eye Visual Performance

ClinicalTrials.gov processed this record on September 30, 2016

To Top