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The Effect of Systane Ultra Lubricant Eye Drops (FID 112903) on Visual Performance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00673764
First received: May 2, 2008
Last updated: January 31, 2012
Last verified: January 2012
History of Changes
  Purpose

To evaluate the effect of 2 different lubricant eye drops on visual function of patients with dry eye


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover 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:
  • Time at Best Corrected Visual Acuity [ Time Frame: 15 minutes, 45 minutes, and 90 minutes post-dose ] [ Designated as safety issue: No ]
    Measuring length of time patient can maintain their best vision while completing a computer task. Performed at 15 minutes, 45 minutes, and 90 minutes post-dose. Corrected visual acuity means the patient can wear glasses or contacts if needed such that the measure is performed with the patient seeing the best that they can.


Secondary Outcome Measures:
  • Functional Blink Rate Time (Time Between Blinks) [ Time Frame: 15 minutes, 45 minutes, and 90 minutes post-dose ] [ Designated as safety issue: No ]
    Measures time in seconds between normal blinks. Performed at 15 minutes, 45 minutes, and 90 minutes post-dose. Longer blink rate time correlates with improved visual performance.


Enrollment: 48
Study Start Date: May 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Systane Ultra
Systane Ultra Lubricant Eye Drops
 Other: Systane Ultra Lubricant Eye Drops
Systane Ultra Lubricant Eye Drops 1 drop each eye one time
Active Comparator: Optive
Optive Lubricant Eye Drops
 Other: Optive Lubricant Eye Drops
Optive Lubricant Eye Drops 1 drop each eye one time

  Eligibility

Ages Eligible for Study:   18 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented diagnosis of dry eye
  • Must not have worn contact lenses for 12 hours prior to Day 1

Exclusion Criteria:

  • Age related
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00673764

Locations
United States, Massachusetts
North Andover
North Andover, Massachusetts, United States, 01845
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00673764     History of Changes
Other Study ID Numbers: C-07-24
Study First Received: May 2, 2008
Results First Received: September 18, 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 June 18, 2013