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Evaluation of SYSTANE Ultra Lubricant Eye Drops

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00702377
First received: June 19, 2008
Last updated: January 31, 2012
Last verified: January 2012
History of Changes
  Purpose

To evaluate the safety and efficacy of two artificial tears in dry eye patients.


Condition Intervention
Dry Eye
 Other: SYSTANE Ultra
Other: Optive

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Tear Break-up Time [ Time Frame: Day 0, Day 7, Day 14, Day 28, and Day 42 ] [ Designated as safety issue: No ]
    Tear breakup time is the time interval between a blink and the development of a dry spot in the tear film. Less than 10 seconds is abnormal. Dry spot is visible after fluorescein staining when viewed under a slit-lamp.

  • Conjunctival Staining [ Time Frame: Day 0, Day 7, Day 14, Day 28, Day 42 ] [ Designated as safety issue: No ]
    Conjunctival staining refers to the appearance of spots on the conjunctiva when dyed with lissamine green stain during an eye examination. Lissamine green temporarily stains the surface of the conjunctiva of the eye. An eye doctor looking at the eye's surface through a slit lamp observes the spots as green spots. Conjunctival staining grading scale is a 6 point scale, with 0 equals no staining (best case) and 6 equals maximum (worst) staining.

  • Corneal Staining [ Time Frame: Day 0, Day 7, Day 14, Day 28, Day 42 ] [ Designated as safety issue: No ]
    Corneal staining refers to the appearance of corneal abrasions when dyed with fluorescein drops during an eye examination. Fluorescein temporarily stains the surface of the cornea of the eye. An eye doctor looking at the eye's surface through a slit lamp observes the abrasions as brightly-colored spots on an otherwise smooth cornea. Corneal staining grading scale is a 15 point scale, with 0 equals no staining (best case) and 15 equals maximum (worst) staining.


Enrollment: 109
Study Start Date: June 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SYSTANE Ultra
SYSTANE Ultra Lubricant Eye Drops
 Other: SYSTANE Ultra
SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
Active Comparator: OPTIVE
OPTIVE Lubricant Eye Drops
 Other: Optive
Optive Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days

  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 eyes
  • Must not have worn contact lenses for 1 week preceding enrollment

Exclusion Criteria:

  • Age related
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00702377

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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00702377     History of Changes
Other Study ID Numbers: C-07-33
Study First Received: June 19, 2008
Results First Received: September 23, 2009
Last Updated: January 31, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
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 23, 2013