NCT04527887

Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease (DEcIDED)

Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Tufts Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective, single-center, randomized, double-masked, parallel comparison, sponsored study seeks to investigate the efficacy of Intracanalicular dexamethasone Insert (IDI) on ameliorating the signs and symptoms of dry eye disease.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	Dextenza (IDI) (Sustained Release Dexamethasone), (0.4 mg)	Intracanalicular dexamethasone insert contains 0.4 mg dexamethasone and is designed to provide a sustained and tapered release of therapeutic levels of dexamethasone to the ocular surface for up to 30 days for the reduction of postsurgical inflammation and pain associated with ocular surgery.
OTHER	ProLong™ collagen plugs	The long term synthetic punctal plug is composed of an absorbable copolymer material and measures 0.4mm in diameter and 2.0mm in length.

Timeline

• Start date: 2020-09-04
• Primary completion: 2023-11-17
• Completion: 2024-12-31
• First posted: 2020-08-27
• Last updated: 2025-01-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study