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Evaluation of Ocular Comfort With ISTA Tears vs Systane

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ClinicalTrials.gov Identifier: NCT01650584
Recruitment Status : Completed
First Posted : July 26, 2012
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Dry Eye Disease Drug: ISTA Tears Drug: Systane

Study Design

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
Primary Completion Date : December 2012
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Systane
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Ocular Comfort [ Time Frame: 30 days ]

Eligibility Criteria

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
Criteria

Inclusion Criteria:

  • OSDI >12

Exclusion Criteria:

  • Presence of any active ocular disease other than dry eye
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01650584


Locations
United States, California
ISTA Pharmaceuticals, Inc.
Irvine, California, United States, 92618
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Tim McNamara, PharmD ISTA Pharmaceuticals, Inc.
More Information

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01650584     History of Changes
Other Study ID Numbers: S00231
First Posted: July 26, 2012    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions