NCT04539548Phase 3Completed

A Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract

Study sponsor: Ocular Therapeutix, Inc. · OCUL

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2023-12-21Actual

Enrollment · participants65Actual

Source updated2024-04-15Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Cataract

Treatments or interventions studied

Dextenza Ophthalmic InsertDrugAlso known as DEXTENZA
Prednisolone acetate ophthalmic suspension USP 1%Drug

Primary outcomes · main study measures

Read the study measures

measure: Adverse Events; description: Number of Ocular Treatment Emergent Adverse Events (TEAEs) and Non-ocular Treatment Emergent Adverse Events (TEAEs); timeFrame: Up to approximately 42 days after surgery; measure: Subject FLACC Pain Assessment; description: Behavioral Observation Pain Rating Scale from 0 (no pain) to 10 (most pain).; timeFrame: From screening through day 42; measure: IOP; description: IOP measured in units of mmHg.; timeFrame: From screening, then day 2 through 42

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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