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Evaluation of the Repeated Usage of Systane Ultra Eyedrop

This study has been completed.
Information provided by (Responsible Party):
Alcon Research Identifier:
First received: January 18, 2010
Last updated: January 31, 2012
Last verified: January 2012
Comparison of two contact lens solutions.

Condition Intervention Phase
Dry Eye Other: Systane Ultra Other: Optive lubricant Eye Drops Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Alcon Research:

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

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

Enrollment: 57
Study Start Date: November 2009
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

Responsible Party: Alcon Research Identifier: NCT01051804     History of Changes
Other Study ID Numbers: SMA-09-33
Study First Received: January 18, 2010
Last Updated: January 31, 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 processed this record on August 17, 2017