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

NCT06235567 | Enrolling By Invitation Phase 1 FDA Drug

• 1 other identifier: 23-40498
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (4)

• Corneal haze

  Assess the efficacy of the dexamethasone insert compared to corticosteroid drops for post-treatment in patients who have had epithelium-off corneal collagen cross linking procedure. This will be assessed by -Postoperative corneal haze as measured by the Physician with a slit lamp biomicroscopy and graded on a scale of 0-4+ (0 = least haze ; 4= most haze)

  1 months (30 days)

• Corneal re-epithelialization

  Assess the efficacy of the dexamethasone insert compared to corticosteroid drops for post-treatment in patients who have had epithelium-off corneal collagen cross linking procedure. This will be assessed by -Physician measured corneal re-epithelialization after bandage contact lens removal by slit lamp biomicroscopy.

  6 months (180 days)

• Keratometry

  Assess the efficacy of the dexamethasone insert compared to corticosteroid drops for post-treatment in patients who have had epithelium-off corneal collagen cross linking procedure. This will be assessed by Postoperative keratometry values (diopters) as measured by corneal topography or Pentacam tomography. Comparing the pre- to post- operative values.

  6 months (180 days)

• Infection

  Adverse event end point: Postoperative infection as measured at any visit.

  6 months (180 days)

Secondary Outcomes (7)

• Comfort

  6 months (180 days)

• Ocular Pain Assessment

  6 months (180 days)

• Ease of insertion

  6 months (180 days)

• Comparison of Ophthalmic Medications for Tolerability Questionnaire

  6 months (180 days)

• IOP spikes incidence

  6 months (180 days)

Study Arms (2)

Dextenza insert

EXPERIMENTAL

This is a prospective, open-label, single-center, randomized, investigator-sponsored clinical study to compare dexamethasone intracanalicular insert and corticosteroid drops for post-treatment in patients undergoing epithelium-off corneal collagen cross linking surgery. The participant's worse eye will be randomized to one of the two treatments, and the fellow eye will receive the alternate treatment when undergoing the procedure at a subsequent date at least three weeks later. There will be a baseline/screening visit, a surgical/ insertion visit for each eye, and follow up visits over 6 months, for a total of 10 visits per patient. The study drug, DEXTNZA, is administered during the surgical procedure and the patient does not need to do any additional steps.

Drug: Dextenza 0.4Mg Ophthalmic Insert

topical prednisolone acetate 1% (PredForte) eye drops

ACTIVE COMPARATOR

This is a prospective, open-label, single-center, randomized, investigator-sponsored clinical study to compare dexamethasone intracanalicular insert and corticosteroid drops for post-treatment in patients undergoing epithelium-off corneal collagen cross linking surgery. The participant's worse eye will be randomized to one of the two treatments, and the fellow eye will receive the alternate treatment when undergoing the procedure at a subsequent date at least three weeks later. There will be a baseline/screening visit, a surgical/ insertion visit for each eye, and follow up visits over 6 months, for a total of 10 visits per patient. 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.

Drug: topical prednisolone acetate 1% (PredForte) eye drops

Interventions

Dextenza 0.4Mg Ophthalmic Insert DRUG

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.

Dextenza insert

topical prednisolone acetate 1% (PredForte) eye drops DRUG

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.

topical prednisolone acetate 1% (PredForte) eye drops

Eligibility Criteria

• Age: 13 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Progressive keratoconus as defined by increasing astigmatism and/or keratometry on corneal topography or tomography or increasing cylindrical error on refraction
• Patients requiring general anesthetic for the procedure
• Preoperative central corneal thickness of \>= 400 microns

You may not qualify if:

• History of acute hydrops in treated eye
• History of pre-existing severe corneal scarring in the treated eye
• History of pre-existing glaucoma in the treated eye
• History of or pharmaceutical treatment of glaucoma or ocular hypertension and history or current spikes in intraocular pressure (IOP) in either eye.
• History of pre-existing ocular inflammation or infection (conjunctivitis, keratitis, uveitis, or retinitis) in treated eye
• Active infectious systemic disease
• Obstructed nasolacrimal duct in the study eye(s)
• Patients with a nasolacrimal duct smaller than 0.4 mm or greater than or equal to 1.0 mm.
• Patients with stenosis to the location where the insert will be placed should be excluded from the study, as the study team would not engage in surgical procedures to expand or surgically correct that region
• Hypersensitivity to dexamethasone
• Patients being treated with immunomodulating agents in the study eye(s)
• Patients being treated with immunosuppressants and/or oral steroids
• Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator

Sponsors & Collaborators

• Maanasa Indaram, MD: lead

Study Sites (3)

Mission Bay Hospital

San Francisco, California, 94158, United States

Location

UCSF Pediatric Ophthalmology

San Francisco, California, 94158, United States

Location

Wayne and Gladys Center for Vision

San Francisco, California, 94158, United States

Location

MeSH Terms

Conditions

Keratoconus

Interventions

Calcium Dobesilate; prednisolone acetate; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Maanasa Indaram, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Clinical Ophthalmology

Model Details: For group A, the study drug, DEXTNZA, is administered during the surgical procedure and the patient does not need to do any additional steps. For group B, 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. The fellow eye will receive the alternate treatment when undergoing the procedure at a subsequent date at least 3 weeks following the first eye, and both within 45 days of the screening visit. Day 0 to Day 30 surgery and assessment schedule will be followed twice, once for each eye.

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: February 1, 2024
• Study Start: April 11, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 24, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)