To assess the safety of Dextenza compared to an active control, prednisolone acetate suspension, for the treatment of postoperative pain and inflammation following ocular surgery for pediatric cataract.
Randomized, parallel-arm, active control, multi-center study assessing the safety of Dextenza for the treatment of ocular pain and inflammation following surgery for pediatric cataract. The subjects will be followed for approximately 2-3 months from screening to the last visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
65
0.4mg insert for intracanalicular use
1 drop at end of surgery, followed by: 1 drop 4 x QID for one week. 1 drop 3 x QID for one week. 1 drop BID for one week. 1 drop QD for one week
Ocular Therapeutix
Aurora, Colorado, United States
Ocular Therapeutix
Fort Collins, Colorado, United States
Ocular Therapeutix
Jacksonville, Florida, United States
Adverse Events
Number of Ocular Treatment Emergent Adverse Events (TEAEs) and Non-ocular Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to approximately 42 days after surgery
Subject FLACC Pain Assessment
Behavioral Observation Pain Rating Scale from 0 (no pain) to 10 (most pain).
Time frame: From screening through day 42
IOP
IOP measured in units of mmHg.
Time frame: From screening, then day 2 through 42
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Ocular Therapeutix
Indianapolis, Indiana, United States
Ocular Therapeutix
Lexington, Kentucky, United States
Ocular Therapeutix
Boston, Massachusetts, United States
Ocular Therapeutix
Minneapolis, Minnesota, United States
Ocular Therapeutix
Rochester, Minnesota, United States
Ocular Therapeutix
St Louis, Missouri, United States
Ocular Therapeutix
Erie, Pennsylvania, United States
...and 4 more locations