NCT06235567

Dextenza Versus Topical Steroid Eye Drops for Postoperative Management Following Corneal Crosslinking

Comparison of Intracanalicular Steroid-eluting Insert (Dextenza) to Topical Steroid Eye Drops for the Postoperative Management of Corneal Collagen Crosslinking

• Status: Enrolling By Invitation
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Maanasa Indaram, MD · Academic / Other
• Sex: All
• Age: 13 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Keratoconus

Interventions

Type	Name	Description
DRUG	Dextenza 0.4Mg Ophthalmic Insert	This insert allows for sustained release of dexamethasone onto the ocular surface over a period of 28 days. It requires a single application and eliminates the potential for noncompliance, difficulty in administration and poor accuracy. Dextenza has been FDA approved for post-operative pain and inflammation following ophthalmic surgery. The pivotal trials included patients undergoing cataract surgery, not CXL surgery. In addition, the age range did not include those of pediatric age.
DRUG	topical prednisolone acetate 1% (PredForte) eye drops	The patient will administer the anti-inflammatory steroid drops on the same 4 week post-operative schedule that is commonly used in standard of care. They will do one drop of Pred Forte in the affected eye 4 times a day for a week, 3 times a day for the second week, 2 times a day for the third week, and once a day for the fourth week.

Timeline

• Start date: 2025-04-11
• Primary completion: 2026-08-01
• Completion: 2026-12-01
• First posted: 2024-02-01
• Last updated: 2026-03-24

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study