This was a randomized, double-masked, vehicle-controlled, Phase 3 study evaluating the efficacy and safety of OCS-01 QD compared to vehicle in the treatment of inflammation and pain following cataract surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
117
Oculis Investigative Site
Glendale, California, United States
Absence of Anterior Chamber Cells at Visit 6.
Time frame: Day 15.
Absence of Ocular Pain at Visit 4.
Time frame: Day 4.
Absence of Anterior Chamber Cells at Visits 4 and 5.
Time frame: Days 4 and 8.
Absence of Ocular Pain at Visits 3, 5, and 6.
Time frame: Days 2, 8, and 15.
Absence of Flare at Visits 4, 5, and 6.
Time frame: Days 4, 8, and 15.
Absence of Both Anterior Chamber Cells and Flare at Visits 4, 5, and 6.
Time frame: Days 4, 8, and 15.
Use of Rescue Medication on or Prior to Each Visit.
Time frame: Days 1, 2, 4, 8, 15, and 22.
Use of Rescue Medication Overall.
Time frame: From first dose until Day 22.
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Oculis Investigative Site
Inglewood, California, United States
Oculis Investigative Site
Newport Beach, California, United States
Oculis Investigative Site
Torrance, California, United States
Oculis Investigative Site
Tamarac, Florida, United States
Oculis Investigative Site
Morrow, Georgia, United States
Oculis Investigative Site
Northbrook, Illinois, United States
Oculis Investigative Site
Indianapolis, Indiana, United States
Oculis Investigative Site
Louisville, Kentucky, United States
Oculis Investigative Site
Woburn, Massachusetts, United States
...and 14 more locations