Clinical trial NCT06235567: Dextenza Versus Topical Steroid Eye Drops for Postoperative Management Following Corneal Crosslinking
Official title: Comparison of Intracanalicular Steroid-eluting Insert (Dextenza) to Topical Steroid Eye Drops for the Postoperative Management of Corneal Collagen Crosslinking
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
PHASE2
Conditions: Keratoconus
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 20
Sex: ALL
Minimum age (years): 13
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* The study will enroll patients age 13 and up with progressive keratoconus (KCN) who are scheduled for bilateral epithelial off corneal collagen cross-linking (CXL) with Photrexa. A patient's study eye must meet the following criteria to be eligible for inclusion in the study:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Corneal haze
timeFrame: 1 months (30 days)
measure: Corneal re-epithelialization
timeFrame: 6 months (180 days)
measure: Keratometry
timeFrame: 6 months (180 days)
measure: Infection
timeFrame: 6 months (180 days)
Secondary outcomes:
measure: Comfort
timeFrame: 6 months (180 days)
measure: Ocular Pain Assessment
timeFrame: 6 months (180 days)
measure: Ease of insertion
timeFrame: 6 months (180 days)
measure: Comparison of Ophthalmic Medications for Tolerability Questionnaire
timeFrame: 6 months (180 days)
measure: IOP spikes incidence
timeFrame: 6 months (180 days)
measure: Anterior segment OCT
timeFrame: 6 months (180 days)
measure: Best Corrected Visual Acuity
timeFrame: 6 months (180 days)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Mission Bay Hospital
state: California
city: San Francisco
country: United States
facility: UCSF Pediatric Ophthalmology
state: California
city: San Francisco
country: United States
facility: Wayne and Gladys Center for Vision
state: California
Study officials:
affiliation: University of California, San Francisco
name: Maanasa Indaram, MD
role: PRINCIPAL_INVESTIGATOR
References: