The DX-216 trial is a randomized, double-masked, placebo (vehicle)-controlled study evaluating the efficacy and safety of two doses of OCS-01 compared to vehicle in the treatment of inflammation and pain following cataract surgery. The primary objective is to evaluate the efficacy and safety of OCS-01 compared to placebo and the secondary objective is to evaluate the optimal dosing frequency (once a day \[QD\] or twice a day \[BID\]).
This is a multi-center, randomized, double-masked, placebo (vehicle)-controlled study, designed to evaluate the efficacy and safety of OCS-01 ophthalmic suspension (QD versus BID) compared to placebo in treating inflammation and pain following cataract surgery. Subjects will be randomized 1:1:1 to receive OCS-01 QD, OCS-01 BID, or placebo BID. Subjects will dose 1 drop in the study eye BID for 14 days, beginning 1 day post-surgery in the operated eye. The study will last up to 24 days, including a follow-up visit at Visit 7 (Day 22 ± 2).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
153
OCS-01 eye drops
Vehicle eye drops
Medical cennre
Petaluma, California, United States
Medical center
Roseburg, Oregon, United States
Medical center
Houston, Texas, United States
Medical center
San Antonio, Texas, United States
Number of Subjects With Absence of Anterior Chamber Cells (i.e. Score of '0')
Absence of anterior chamber cells as measured by slit beam with fluorescein. The anterior chamber cell count was recorded as the actual number of cells observed if ≤10 cells were seen, otherwise a range was reported. The observed anterior chamber cell count at Visit 6 was used and categorized for analysis as follows: * Absence of anterior chamber cells: anterior chamber cell count of 0 / Grade 0 * Presence of anterior chamber cells: anterior chamber cell count of 1 or more / Grade 1, 2, 3, or 4
Time frame: at Day 15 (visit 6)
Number of Subjects With Absence of Ocular Pain (i.e. Score of '0')
Absence of pain as assessed by Ocular Pain Grading Scale (Min 0, Max 10) in which 0 is no pain and 10 is the worst possible. Ocular pain was assessed by the patient at screening and at each follow-up visit, utilizing a numerical pain rating scale. Scores ranged from 0 to 10, where 0 = No Pain and 10 = Severe Pain, such that larger scores corresponded to higher levels of pain.
Time frame: at Day 4 (visit 4)
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