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

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ClinicalTrials.gov Identifier: NCT00673764
Recruitment Status : Completed
First Posted : May 7, 2008
Results First Posted : February 10, 2010
Last Update Posted : February 2, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To evaluate the effect of 2 different lubricant eye drops on visual function of patients with dry eye

Condition or disease Intervention/treatment
Dry Eye Other: Systane Ultra Lubricant Eye Drops Other: Optive Lubricant Eye Drops

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : May 2008
Primary Completion Date : June 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Time at Best Corrected Visual Acuity [ Time Frame: 15 minutes, 45 minutes, and 90 minutes post-dose ]
    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 :
  1. Functional Blink Rate Time (Time Between Blinks) [ Time Frame: 15 minutes, 45 minutes, and 90 minutes post-dose ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00673764


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

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00673764     History of Changes
Other Study ID Numbers: C-07-24
First Posted: May 7, 2008    Key Record Dates
Results First Posted: February 10, 2010
Last Update Posted: February 2, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Ophthalmic Solutions
Tetrahydrozoline
Lubricant Eye Drops
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents