Evaluation of Ocular Comfort With ISTA Tears vs Systane
1 other identifier
interventional
35
1 country
1
Brief Summary
To assess the comfort preference of ISTA Tears vs Systane in patients with dry eye disease (DED)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 24, 2012
CompletedFirst Posted
Study publicly available on registry
July 26, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedResults Posted
Study results publicly available
October 6, 2020
CompletedOctober 8, 2024
September 1, 2020
6 months
July 24, 2012
August 24, 2020
October 1, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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.
30 days
Study Arms (2)
ISTA Tears
EXPERIMENTALSterile ophthalmic solution
Systane
ACTIVE COMPARATORSterile ophthalmic solution
Interventions
Eligibility Criteria
You may qualify if:
- OSDI \>12
You may not qualify if:
- Presence of any active ocular disease other than dry eye
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ISTA Pharmaceuticals, Inc.
Irvine, California, 92618, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Bausch Health
Study Officials
- STUDY DIRECTOR
Tim McNamara, PharmD
ISTA Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2012
First Posted
July 26, 2012
Study Start
June 1, 2012
Primary Completion
December 1, 2012
Study Completion
January 1, 2013
Last Updated
October 8, 2024
Results First Posted
October 6, 2020
Record last verified: 2020-09