A Phase 3 interventional study of Dextenza Ophthalmic Insert and Prednisolone acetate ophthalmic suspension USP 1% in Cataract, sponsored by Ocular Therapeutix, Inc.. Completed at 14 sites in United States. Open to participants aged 0 Years to 5 Years. Per ClinicalTrials.gov, last updated 2024-04-15.
Sponsored by Ocular Therapeutix, Inc. · Phase 3, Interventional, and Treatment
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.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's enrollment of 65 is below the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →Ocular Therapeutix, Inc. is the lead sponsor of 32 studies on the registry; 2 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 6 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1 dosing group - 37 eyes treated with Dextenza
Drug: Dextenza Ophthalmic Insert
1 dosing group - 32 eyes treated with Prednisolone
Drug: Prednisolone acetate ophthalmic suspension USP 1%
0.4mg insert for intracanalicular use
Also known as: DEXTENZA
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
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
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Ocular Therapeutix, Inc.