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To Evaluate the Physical Effects of Systane(R) Lubricant Eye Drops Compared to Refresh Tears(R) Lubricant Eye Drops

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01160133
First Posted: July 12, 2010
Last Update Posted: April 10, 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
This is a multi-site, randomized, investigator-masked study to evaluate the physical effects of Systane(R) versus Refresh Tears(R) in subjects with moderate to severe dry eye. It is a 6-week, perspective, randomized, active-controlled, investigator-masked, parallel group study.

Condition Intervention
Dry Eye Other: Systane Other: Refresh Tears

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • To evaluate physical effects of Systane and Refresh Tears in subjects to moderate to severe dry eye. [ Time Frame: Baseline to visit 3 (Day 42) ]
    This is a descriptive study in which changes from baseline in Tear Break up Time, corneal staining, and the Ocular Symptoms Questionnaire will be evaluated by treatment group at every visit. The outcome of the IDEEL questionnaire at Visit 3 will be compared to Visit 1 by treatment group; the results of treatment satisfaction questionnaires will be tabulated by treatment at Visit 3.


Enrollment: 78
Study Start Date: July 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Systane
Systane Lubricant Eye Drops
Other: Systane
Systane Lubricant Eye Drops (1-2 drops in each eye, four times per day)
Experimental: Refresh Tears
Refresh Tears Lubricant Eye Drops
Other: Refresh Tears
Refresh Tears Lubricant Eye Drops (1-2 drops in each eye, four times per day)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must be 18 years of age or older of any sex and any race, with a score of at least 2 (some of the time) on the subject-assessed Symptom Eligibility question.
  • A sodium fluorescein corneal staining sum of ≥ 3 in either eye.
  • A best-corrected visual acuity of 0.6 logMAR or better in each eye as assessed using an ETDRS chart.

Exclusion Criteria:

  • A history or evidence of ocular or intraocular surgery in either eye within the past 6 months.
  • Lasik patients can be included if lasik surgery was greater than 6 months prior to the initiation of the study.
  • A history of intolerance or hypersensitivity to any component of the study medications.
  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): NCT01160133


Locations
India
Vasan Eye Care Hospital
Saidapet, Channai, India, 600 015
Sponsors and Collaborators
Alcon Research
  More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01160133     History of Changes
Other Study ID Numbers: SMA-09-67
First Submitted: July 9, 2010
First Posted: July 12, 2010
Last Update Posted: April 10, 2012
Last Verified: January 2012

Keywords provided by Alcon Research:
Systane
Refresh Tears
Dry Eye
Moderate to Severe Dry Eye

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