Evaluation of the Repeated Usage of Systane Ultra Eyedrop

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: NCT01051804
Recruitment Status : Completed
First Posted : January 20, 2010
Last Update Posted : February 2, 2012
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
Comparison of two contact lens solutions.

Condition or disease Intervention/treatment Phase
Dry Eye Other: Systane Ultra Other: Optive lubricant Eye Drops Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Study Start Date : November 2009
Actual Primary Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Systane Ultra
Systane Ultra Lubricant Eye Drops
Other: Systane Ultra
Systane Ultra 1 to 2 drops per eye at least 4 times daily for 4 weeks
Active Comparator: Optive
Optive Lubricant Eye Drops
Other: Optive lubricant Eye Drops
Optive Lubricant Eye Drops 1 to 2 drops per eye at least 4 times daily for 4 weeks

Primary Outcome Measures :
  1. Improvement in objective vision [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Measurement of tear film evaporation [ Time Frame: 4 weeks ]

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

Inclusion Criteria:

  • Age 18 years or more.
  • Non contact lens wearer.
  • Symptomatology as defined below for the Ocular Surface Disease Index (OSDI) questionnaire:

    • Score ≥13 for OSDI Questionnaire total score; AND
    • Scores of at least 2 for 2 out of the 6 vision related questions of the OSDI questionnaire
  • Best visual acuity of 6/9 or better in each eye.
  • Willingness to adhere to the instructions set in the clinical protocol.
  • Signature of the subject informed consent form.

Exclusion Criteria:

  • Use of systemic medication which might produce dry eye side effects.
  • Systemic disease which might produce dry eye side effects.
  • Active ocular infection.
  • Use of ocular medication.
  • Significant ocular anomaly.
  • Previous ocular surgery
  • Previous use of Restasis
  • Any medical condition that might be prejudicial to the study.
  • The subject, based on their knowledge, must NOT be pregnant or lactating at the time of enrolment.
  • The subject, based on his/her knowledge, must NOT have an infectious disease (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. Human Immunodeficiency Virus).
  • The subject, based on their knowledge, must NOT have diabetes.

Responsible Party: Alcon Research Identifier: NCT01051804     History of Changes
Other Study ID Numbers: SMA-09-33
First Posted: January 20, 2010    Key Record Dates
Last Update Posted: February 2, 2012
Last Verified: January 2012

Keywords provided by Alcon Research:
Dry eye
Visual Performance

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