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

Part of paid clinical trials in San Francisco, California.

Sponsor
Maanasa Indaram, MD
Study ID
NCT06235567
Phase
PHASE1/PHASE2
Status
Enrolling By Invitation

Conditions

  • Keratoconus

Eligibility Criteria

Sex
ALL
Age
13 Years - 64 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Apr 11, 2025
Status verified
Jun 2025
Primary completion
Aug 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dextenza insert
    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.
  • Active Comparator: topical prednisolone acetate 1% (PredForte) eye drops
    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.

Primary Outcome Measure

Corneal haze [ Time Frame: 1 months (30 days) ]

Locations (3)

FacilityCityStateZIPSite coordinators
Mission Bay HospitalSan FranciscoCalifornia94158-
UCSF Pediatric OphthalmologySan FranciscoCalifornia94158-
Wayne and Gladys Center for VisionSan FranciscoCalifornia94158-

Find similar trials in San Francisco, CA

By research site
Mission Bay Hospital· San Francisco, CAUCSF Pediatric Ophthalmology· San Francisco, CAWayne and Gladys Center for Vision· San Francisco, CA

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