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Acute Comfort and Blur of Systane Ultra and Systane

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.
ClinicalTrials.gov Identifier: NCT00748865
Recruitment Status : Completed
First Posted : September 9, 2008
Results First Posted : March 11, 2010
Last Update Posted : February 2, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
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 or disease Intervention/treatment
Dry Eye Other: Systane Ultra Lubricant Eye Drops Other: Systane Lubricant Eye Drops

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : July 2008
Primary Completion Date : August 2008
Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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,



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

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

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00748865     History of Changes
Other Study ID Numbers: M-08-09
First Posted: September 9, 2008    Key Record Dates
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