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

NCT06235567 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-03-24

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Maanasa Indaram, MD

    lead OTHER

Principal Investigators

  • Maanasa Indaram, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-11
Primary Completion
2026-08-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06235567 on ClinicalTrials.gov