Dextenza for Corneal Crosslinking

Status Enrolling by invitation

Clinical Trial Summary

This study aims to compare the use of Dextenza, an FDA-approved intracanilular drug-eluting insert that is designed to deliver a tapered dose of dexamethasone to the ocular surface for 30 days, to the standard of care, or the use of a month-long topical prednisolone acetate 1% (PredForte) eye drops starting from four times daily. Following treatment, Dextenza resorbs and exits the nasolacrimal system without the need for removal. Three prior phase 3 clinical trials have demonstrated that Dextenza is equally efficacious to a month-long topical Pred Forte taper in the treatment of postoperative inflammation following cataract surgery. This proposed study strives to demonstrate the non-inferiority of using Dextenza to treat postoperative inflammation following corneal collagen crosslinking compared to standard of care eye drops in a randomized trial. By demonstrating Dextenza's non-inferiority to treatment postoperative inflammation, the investigators hope to provide an alternative modality of treatment to patients who are unable to cooperate with or tolerate postoperative topical eye drop regimens, allowing for improved adherence to necessary therapy and thus improved postoperative outcomes.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Keratoconus

Clinical Trial Details

NCT number	NCT06235567
Study type	Interventional
Source	University of California, San Francisco
Contact
Status	Enrolling by invitation
Phase	Phase 1/Phase 2
Start date	April 2024
Completion date	December 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04570020` - Scleral Lens Fitting Using Wide-Field OCT
Recruiting	`NCT02921009` - McNeel Eye Center Corneal Crosslinking Study	N/A
Completed	`NCT01691651` - Botulinum Toxin A for the Treatment of Keratoconus	N/A
Terminated	`NCT02762253` - Study of the Safety and Effectiveness of Photochemically Induced Collagen Cross-Linking in Eyes With Keratoconus.	Phase 2
Completed	`NCT01527708` - Accuracy of Curvature and Wavefront Aberrations of Posterior Corneal Surface, in Keratoconic and Post-CXL Corneas	N/A
Completed	`NCT01527721` - Blurring Strength & Aberrometric Changes Following Corneal Cross-linking (CxL) and CxL Combined With Photorefractive Keratectomy (PRK) in Keratoconus	N/A
Recruiting	`NCT00841386` - Treatment of Keratoconus Using Collagen Cross-Linking	Phase 2/Phase 3
Completed	`NCT00347074` - A Clinical Study of Keratoconus in Asian Patients and Assessment of Different Topographic Patterns of Keratoconus in Asian Patients	N/A
Completed	`NCT03187912` - Accelerated Corneal Cross-linking With Different Riboflavin Solutions	Phase 3
Completed	`NCT00584285` - Corneal Topographer Fluorescein Patterns
Completed	`NCT03511495` - Reliability of Topography Measurements in Keratoconus
Not yet recruiting	`NCT05395650` - Cyanocobalamin as Photosensitizing Agent
Completed	`NCT04418999` - Safety and Efficacy of Intracanalicular Dexamethasone Compared to Loteprednol Etabonate in Patients With Keratoconus	Early Phase 1
Completed	`NCT05019768` - Topo-pachimetric Accelerated Epi-On Cross-linking Compared to Dresden Protocol Using Riboflavin With Vitamin E TPGS	N/A
Completed	`NCT03235856` - Retrospective Digital Computer Analysis of Keratoconus Evolution - REDCAKE
Withdrawn	`NCT01789333` - Higher Irradiance in Keratoconus Ectasia	N/A
Completed	`NCT05114928` - Correlation Between Q-value Changes and Progression of Pediatric Keratoconus.
Completed	`NCT03647046` - Custom Anterior Surfacing of Scleral Lens for Vision Quality Improvement in Patients With Keratoconus	N/A
Recruiting	`NCT04439552` - fMRI and IVCM Cornea Microscopy of CXL in Keratoconus
Recruiting	`NCT06100939` - Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age With Keratoconus	Phase 3