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

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. Identifier: NCT01160133
Recruitment Status : Completed
First Posted : July 12, 2010
Last Update Posted : April 10, 2012
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
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 or disease Intervention/treatment Phase
Dry Eye Other: Systane Other: Refresh Tears Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : July 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
Drug Information available for: Systane

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. 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.

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.

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

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.

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 identifier (NCT number): NCT01160133

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

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Responsible Party: Alcon Research Identifier: NCT01160133    
Other Study ID Numbers: SMA-09-67
First Posted: July 12, 2010    Key Record Dates
Last Update Posted: April 10, 2012
Last Verified: January 2012
Keywords provided by Alcon Research:
Refresh Tears
Dry Eye
Moderate to Severe Dry Eye
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Lubricant Eye Drops
Pharmaceutical Solutions