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Acute Comfort and Blur of Systane and Optive

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00568386
First received: December 5, 2007
Last updated: January 31, 2012
Last verified: January 2012
History of Changes
  Purpose

To evaluate drop comfort, acceptability, preference and blur profile between two marketed artificial tears in both dry eye and non-dry eye patient population.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Acute Comfort and Blurring Profile Evaluation Comparing Systane Lubricant Eye Drops to Optive Lubricant Eye Drops

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Visual Blur [ Time Frame: 3 minutes post dose ] [ Designated as safety issue: No ]
    Visual blur profile is a visual scale ranging from 0 (no blur) to 50 (most blurry). Patients were asked to rate there vision on a specific focal point (an object in the room) through 3 minutes.


Enrollment: 40
Study Start Date: November 2007
Study Completion Date: December 2007
Arms Assigned Interventions
Experimental: Systane Lubricant Eye Drops
Systane Lubricant Eye Drops 1 drop in each eye one time
 Other: Systane Lubricant Eye Drops
Systane Lubricant Eye Drops 1 drop each eye once time
Active Comparator: Optive Lubricant Eye Drops
Optive Lubricant Eye Drops 1 drop each one time
 Other: Optive Lubricant Eye Drops
Optive 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:   Yes
Criteria

Inclusion Criteria:

  • Healthy, normal eyes OR documented diagnosis of dry eye

Exclusion Criteria:

  • Must not have worn contact lenses for 7 days preceding enrollment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00568386

Sponsors and Collaborators
Alcon Research
Investigators
Principal Investigator: Mike Christensen Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00568386     History of Changes
Other Study ID Numbers: M-07-02
Study First Received: December 5, 2007
Results First Received: December 18, 2008
Last Updated: January 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Dry eye

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