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Enrolling by Invitation

NCT Number: NCT06235567

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

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.

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Key information

Conditions

Keratoconus Corneal Diseases Eye Diseases

Age range

13 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Mission Bay Hospital, San Francisco, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

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

Treatment and study plan

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.

Primary outcomes

  1. Corneal haze

    Time frame: 1 months (30 days)

    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)

  2. Corneal re-epithelialization

    Time frame: 6 months (180 days)

    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.

  3. Keratometry

    Time frame: 6 months (180 days)

    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.

  4. Infection

    Time frame: 6 months (180 days)

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

Secondary outcomes

  1. Comfort

    Time frame: 6 months (180 days)

    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)

  2. Ocular Pain Assessment

    Time frame: 6 months (180 days)

    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)

  3. Ease of insertion

    Time frame: 6 months (180 days)

    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)

  4. Comparison of Ophthalmic Medications for Tolerability Questionnaire

    Time frame: 6 months (180 days)

    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)

  5. IOP spikes incidence

    Time frame: 6 months (180 days)

    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. Anterior segment OCT

    Time frame: 6 months (180 days)

    To determine the effect of dexamethasone intracanalicular insert through day 180 as measured by:

    • Anterior segment OCT findings mean change from baseline

  7. Best Corrected Visual Acuity

    Time frame: 6 months (180 days)

    To determine the effect of dexamethasone intracanalicular insert through day 180 as measured by:

    • Best corrected visual acuity mean change from baseline as measured

Sponsors and collaborators

Lead sponsor

Maanasa Indaram, MD

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 1, 2024
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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