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Acute Comfort and Blur of Systane Ultra and Systane

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00748865
First received: September 5, 2008
Last updated: January 31, 2012
Last verified: January 2012
History of Changes
  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 Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Drop Comfort [ Time Frame: once upon instillation ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00748865     History of Changes
Other Study ID Numbers: M-08-09
Study First Received: September 5, 2008
Results First Received: September 25, 2009
Last Updated: January 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Dry Eye
Artificial Tears

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Tetrahydrozoline
 Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013