The objective of this trial is to evaluate safety and tolerability of CyclASol during long-term use in subjects with Dry Eye Disease.
Phase 3 multicenter, open-label, single-arm clinical trial to evaluate the safety, tolerability and efficacy of CyclASol in subjects with signs and symptoms of Dry Eye Disease. Subjects who completed the trial CYS-004, had a subject-reported history of dry eye in both eyes and met all other study eligibility criteria were dosed CyclASol bilaterally BID for 12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
202
Cyclosporine A solution in vehicle
CYS-005 Investigational Site
Los Angeles, California, United States
CYS-005 Investigational Site
Newport Beach, California, United States
CYS-005 Investigational Site
Number of Subjects Reporting Any Adverse Events
An adverse event was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not the event was considered drug related. 200 participants from the safety set were analyzed.
Time frame: 12 months
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Carmel, Indiana, United States
CYS-005 Investigational Site
Louisville, Kentucky, United States
CYS-005 Investigational Site
Andover, Massachusetts, United States
CYS-005 Investigtional Site
Raynham, Massachusetts, United States
CYS-005 Investigational Site
Henderson, Nevada, United States
CYS-005 Investigational Site
Raleigh, North Carolina, United States
CYS-005 Investigational Site
Shelby, North Carolina, United States
CYS-005 Investigational Site
Fargo, North Dakota, United States
...and 4 more locations