Safety and Efficacy of Dexamethasone Ophthalmic Insert (Dextenza®) in the Management of Clinically Significant Dry Eye

Phase 4 Terminated 77 enrolled Johns Hopkins University

RandomizedSingle-groupDouble-blindTreatment

Summary

To determine efficacy and safety profile of dexamethasone 0.4mg lacrimal insert in dry eye related ocular surface inflammation.

Timeline

Start: 2021-03-16
Primary completion: 2023-03-03
Completion: 2023-03-03

Outcome

Mixed primary results

Stopped (Enrollment): “The study was terminated prematurely due to administrative reasons; loss of several research personnel. Because of strict eligibility criteria, the investigators anticipated delays in completing enrollment and therefore decided to terminate early.”

registry analysis (superiority test); Treatment Arm vs Control Arm; p = 0.003; Mean Difference (Final Values) -0.55 (95% CI -0.91 to -0.19); t-test, 2 sided NCT04498468 ↗

registry analysis (superiority test); Treatment Arm vs Control Arm; p = 0.069; Mean Difference (Final Values) -5.5 (95% CI -11.4 to 0.4); t-test, 2 sided NCT04498468 ↗

Publications

Lin MX, Guo L, Saldanha IJ, VanCourt S, Zeng J, Karakus S, Hessen M, Li G, Akpek EK. Dexamethasone Intracanalicular Insert for Clinically Significant Aqueous-Deficient Dry Eye: A Randomized Controlled Trial. Ophthalmology. 2024 Sep;131(9):1033-1044. doi: 10.1016/j.ophtha.2024.03.010. Epub 2024 Mar 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dexamethasone	Small molecule	0.4 mg	Other