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Evaluation of Ocular Comfort With ISTA Tears vs Systane

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: NCT01650584
Recruitment Status : Completed
First Posted : July 26, 2012
Results First Posted : October 6, 2020
Last Update Posted : October 6, 2020
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Brief Summary:
To assess the comfort preference of ISTA Tears vs Systane in patients with dry eye disease (DED)

Condition or disease Intervention/treatment Phase
Dry Eye Disease Drug: ISTA Tears Drug: Systane Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Ocular Comfort With ISTA Tears vs Systane
Study Start Date : June 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases Tears
Drug Information available for: Systane

Arm Intervention/treatment
Experimental: ISTA Tears
Sterile ophthalmic solution
Drug: ISTA Tears
sterile ophthalmic solution

Active Comparator: Systane
Sterile ophthalmic solution
Drug: Systane
Sterile ophthalmic solution

Primary Outcome Measures :
  1. Percentage of Participants With Preference for One of the Treatments [ Time Frame: 30 days ]
    There were 35 participants who applied ISTA Tears to the right eye and Systane to the left eye (70 eyes total). Participants were asked to indicate which treatment they preferred, or if they preferred neither.

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:

  • OSDI >12

Exclusion Criteria:

  • Presence of any active ocular disease other than dry eye

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): NCT01650584

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United States, California
ISTA Pharmaceuticals, Inc.
Irvine, California, United States, 92618
Sponsors and Collaborators
Bausch & Lomb Incorporated
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Study Director: Tim McNamara, PharmD ISTA Pharmaceuticals, Inc.
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Responsible Party: Bausch & Lomb Incorporated Identifier: NCT01650584    
Other Study ID Numbers: S00231
First Posted: July 26, 2012    Key Record Dates
Results First Posted: October 6, 2020
Last Update Posted: October 6, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Eye Diseases
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctival Diseases
Corneal Diseases
Lacrimal Apparatus Diseases