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
  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:


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
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:

  • None.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

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

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on April 17, 2014