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Acute Comfort and Blur of Systane Ultra and Systane

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00748865
First Posted: September 9, 2008
Last Update Posted: February 2, 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
To evaluate drop comfort, acceptability, preference and blue profile between two marketed artificial tears in both dry eyes and non-dry eye patient population.

Condition Intervention
Dry Eye Other: Systane Ultra Lubricant Eye Drops Other: Systane Lubricant Eye Drops

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Drop Comfort [ Time Frame: once upon instillation ]
    Drop comfort grading scale is a 0 to 9 scale, with 0 meaning most comfortable and 9 meaning most uncomfortable,


Enrollment: 20
Study Start Date: July 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Systane Ultra
Systane Ultra 1 drop each eye one time
Other: Systane Ultra Lubricant Eye Drops
Systane Ultra Lubricant Eye Drops 1 drop each eye one time
Active Comparator: Systane
Systane 1 drop each eye one time
Other: Systane Lubricant Eye Drops
Systane Lubricant Eye Drops 1 drop each eye one time

  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:   No
Criteria

Inclusion Criteria:

  • Documented diagnosis of dry eye

Exclusion Criteria:

  • Use of contact lens within 7 days preceding enrollment
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00748865


Locations
United States, Texas
Contact Alcon Call Center for Trial Location
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00748865     History of Changes
Other Study ID Numbers: M-08-09
First Submitted: September 5, 2008
First Posted: September 9, 2008
Results First Submitted: September 25, 2009
Results First Posted: March 11, 2010
Last Update Posted: February 2, 2012
Last Verified: January 2012

Keywords provided by Alcon Research:
Dry Eye
Artificial Tears

Additional relevant MeSH terms:
Ophthalmic Solutions
Tetrahydrozoline
Lubricant Eye Drops
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents