NCT05116345

DEXTENZA for the Treatment of Pain and Inflammation Following Surgical Trabeculectomy and Ahmed Valve Procedures

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Brian Jerkins, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a prospective, comparative, open-label, single-center, randomized, investigator-sponsored clinical study and seeks to investigate clinical outcomes with standard of care and high dose DEXTENZA treatment compared to standard of care topical dexamethasone in patients undergoing trabeculectomy, trabeculectomy Ex-PRESS, Xen Gel stent, and Ahmed Valve surgery. Patients will be followed through 6 months. After screening a given patient for inclusion and exclusion criteria, and gaining informed consent, eyes of n=30 patients will be randomized to one of the following two groups (n=15per group) and followed from Baseline through Month 6.

Conditions

• Glaucoma Following Surgery

Interventions

Type	Name	Description
DRUG	DEXTENZA	Intracanalicular Dexamethasone ophthalmic insert (0.4mg)
DRUG	Topical Dexamethasone	topical dexamethasone drops

Timeline

• Start date: 2021-11-01
• Primary completion: 2023-11-01
• Completion: 2023-11-01
• First posted: 2021-11-11
• Last updated: 2021-11-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study