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Evaluation of Lubricant Eye Drops
This study has been completed.
Sponsored by: Alcon Research
Information provided by: Alcon Research
ClinicalTrials.gov Identifier: NCT00702377
  Purpose

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


Condition Intervention
Dry Eye
Drug: SYSTANE Ultra

Drug Information available for: Tetrahydrozoline Tetrahydrozoline hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Tear break-up time Corneal staining Conjunctival staining Ocular symptoms and treatment satisfaction Ocular surface disease index Visual function Adverse Events [ Time Frame: From baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
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
1: Experimental
SYSTANE Ultra
Drug: SYSTANE Ultra
Lubricant Eye Drops
2: Active Comparator
OPTIVE Lubricant Eye Drops (Allergan)
Drug: SYSTANE Ultra
Lubricant Eye Drops

  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

Responsible Party: Alcon ( Mike Christensen )
Study ID Numbers: C-07-33
Study First Received: June 19, 2008
Last Updated: September 24, 2008
ClinicalTrials.gov Identifier: NCT00702377  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Tetrahydrozoline

ClinicalTrials.gov processed this record on January 15, 2009