We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00673764
First Posted: May 7, 2008
Last Update Posted: February 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alcon Research
  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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


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 ]
    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 ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: May 2, 2008
First Posted: May 7, 2008
Results First Submitted: September 18, 2009
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