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Clinical Trial Summary

This a prospective study review of the clinical efficacy of DEXTENZA for the treatment of anterior uveitis compared to the standard of care topical corticosteroid treatment


Clinical Trial Description

Patients with anterior uveitis are typically treated aggressively with every 1-2 hour (while the patient is awake) potent topical steroid agents, during initial stage of inflammation, and evaluated at frequent intervals, with a schedule of steroid tapering dictated by clinical response. The most common topical corticosteroid prescribed for the treatment of anterior uveitis are prednisolone acetate 1%, dexamethasone 0.1%, prednisolone sodium phosphate 1% and Difluprednate 0.05%. However, topical treatments are limited by the potential for patient non-adherence and variation in drug concentrations due to the intermittent or suspension of use nature of application. A corticosteroid insert placed in the inferior and superior canaliculi provides the advantages of reliable and continuous drug delivery for 24 hours a day for 30 days without the need for patients to adhere to a treatment regimen. Dextenza is a sustained-release dexamethasone intracanalicular insert recently approved by the FDA for pain and inflammation post ophthalmic surgery. Dextenza was shown to decrease inflammation and pain compared with placebo following cataract surgery in a multicenter randomized clinical trial. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04426734
Study type Interventional
Source New England Retina Associates
Contact John Huang
Phone 2032882020
Email jjqhuang@yahoo.com
Status Not yet recruiting
Phase Phase 4
Start date July 1, 2020
Completion date March 31, 2021

See also
  Status Clinical Trial Phase
Completed NCT05042609 - A Study of TRS01 in Subjects With Active Non-infectious Anterior Uveitis Including Subjects With Uveitic Glaucoma Phase 3
Completed NCT02309385 - Safety and Efficacy Study of DSP-Visulex for the Treatment of Anterior Uveitis Phase 1/Phase 2
Completed NCT02406209 - A Safety and Efficacy Study of NS2 in Patients With Anterior Uveitis Phase 2
Completed NCT04222712 - A Study to Evaluate TRS01 Eye Drops in Participants With Active Non-infectious Anterior Uveitis Phase 1/Phase 2
Completed NCT03131154 - SOLACE Trial - A Phase 3 Trial in Subjects With Non-infectious Anterior-uveitis. Phase 3