COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

Layout table for study information
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

Drug Information available for: Systane

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

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.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.
Layout table for additonal information
Responsible Party: Alcon Research Identifier: NCT01051804    
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:
Layout table for MeSH terms
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Lubricant Eye Drops
Pharmaceutical Solutions