A Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract
NCT04539548Phase 3Completed
- Lead sponsor
- Ocular Therapeutix, Inc. (Industry)
- Enrollment
- 65 (actual)
- Start date
- 4 Sep 2020
- Primary completion
- 21 Dec 2023 (actual)
- Study completion
- 21 Dec 2023
- Last update posted
- 15 Apr 2024
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- None
- Arms
- 2
Interventions
- Dextenza Ophthalmic Insert Drug
- Prednisolone acetate ophthalmic suspension USP 1% Drug
Conditions and primary outcome
- Cataract
Primary outcome
Adverse Events (Up to approximately 42 days after surgery); Subject FLACC Pain Assessment (From screening through day 42); IOP (From screening, then day 2 through 42)
Posted results on ClinicalTrials.gov
Results posted on ClinicalTrials.gov: No
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
No PubMed citation lists NCT04539548.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT04539548 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Nothing on this page is medical or investment advice.