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
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

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 August 28, 2014