Back to resultsEvaluation of Ocular Comfort With ISTA Tears vs Systane
Primary Purpose
Dry Eye Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ISTA Tears
Systane
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Disease
Eligibility Criteria
Inclusion Criteria:
- OSDI >12
Exclusion Criteria:
- Presence of any active ocular disease other than dry eye
Sites / Locations
- ISTA Pharmaceuticals, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ISTA Tears
Systane
Arm Description
Sterile ophthalmic solution
Sterile ophthalmic solution
Outcomes
Primary Outcome Measures
Percentage of Participants With Preference for One of the Treatments
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01650584
First Posted
July 24, 2012
Last Updated
September 11, 2020
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT01650584
Brief Title
Evaluation of Ocular Comfort With ISTA Tears vs Systane
Official Title
Evaluation of Ocular Comfort With ISTA Tears vs Systane
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To assess the comfort preference of ISTA Tears vs Systane in patients with dry eye disease (DED)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ISTA Tears
Arm Type
Experimental
Arm Description
Sterile ophthalmic solution
Arm Title
Systane
Arm Type
Active Comparator
Arm Description
Sterile ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
ISTA Tears
Intervention Description
sterile ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Systane
Intervention Description
Sterile ophthalmic solution
Primary Outcome Measure Information:
Title
Percentage of Participants With Preference for One of the Treatments
Description
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.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
OSDI >12
Exclusion Criteria:
Presence of any active ocular disease other than dry eye
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim McNamara, PharmD
Organizational Affiliation
ISTA Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
ISTA Pharmaceuticals, Inc.
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Ocular Comfort With ISTA Tears vs Systane
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