Dextenza for Corneal Crosslinking

Keratoconus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06235567
• Other study ID #: 23-40498
• Status: Enrolling by invitation
• Phase: Phase 1/Phase 2
• Start date: April 2024
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Keratoconus

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Mission Bay Hospital	San Francisco	California
United States	UCSF Pediatric Ophthalmology	San Francisco	California
United States	Wayne and Gladys Center for Vision	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Maanasa Indaram, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	6 months (180 days)
Primary	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)
Primary	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)
Primary	Infection	Adverse event end point: Postoperative infection as measured at any visit.	6 months (180 days)
Secondary	Comfort	To determine the effect of dexamethasone intracanalicular insert through day 180 as measured by: - Patient comfort postoperatively as measured by a 0-10 scale and determined by asking the patient (0= no comfort; 10= maximum comfort)	6 months (180 days)
Secondary	Ocular Pain Assessment	To determine the effect of dexamethasone intracanalicular insert through day 180 as measured by: - Patient pain postoperatively as measured by a 0-10 scale and determined by asking the patient (0= no pain ; 10= maximum pain)	6 months (180 days)
Secondary	Ease of insertion	To determine the effect of dexamethasone intracanalicular insert through day 180 as measured by: - Physician ease of insertion as measured by a 0-5-point scale (0= easy insertion ; 5= difficult insertion)	6 months (180 days)
Secondary	Comparison of Ophthalmic Medications for Tolerability Questionnaire	To determine the effect of dexamethasone intracanalicular insert through day 180 as measured by: - Patient's and caregivers' therapy of preference as measured by the Comparison of Ophthalmic Medications for Tolerability Questionnaire (COMTOL)	6 months (180 days)
Secondary	IOP spikes incidence	To determine the effect of dexamethasone intracanalicular insert through day 180 as measured by: - Incidence of IOP spikes (IOP increased >or = 10mmHg from baseline) measured	6 months (180 days)
Secondary	Anterior segment OCT	To determine the effect of dexamethasone intracanalicular insert through day 180 as measured by: - Anterior segment OCT findings mean change from baseline	6 months (180 days)
Secondary	Best Corrected Visual Acuity	To determine the effect of dexamethasone intracanalicular insert through day 180 as measured by: - Best corrected visual acuity mean change from baseline as measured	6 months (180 days)