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Corticosteroid

Dextenza for Keratoconus

Phase 1 & 2

Waitlist Available

Research Sponsored by Maanasa Indaram, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients requiring general anesthetic for the procedure

Patients age 13 and up with progressive keratoconus (KCN) who are scheduled for bilateral epithelial off corneal collagen cross-linking (CXL) with Photrexa

Must not have

Patients with a nasolacrimal duct smaller than 0.4 mm or greater than or equal to 1.0 mm

History of acute hydrops in treated eye

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months (180 days)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to compare the use of Dextenza, a small drug-eluting insert, to the standard eye drops for treating inflammation after corneal collagen crosslinking. Previous studies have shown

Who is the study for?

This trial is for individuals with Keratoconus, a condition affecting the eye's cornea. Participants should be those who require treatment for inflammation after undergoing corneal collagen crosslinking surgery. The study seeks people who may struggle with standard postoperative eye drop treatments.

What is being tested?

The trial is testing Dextenza, an FDA-approved insert that releases dexamethasone into the eye over 30 days, against traditional prednisolone acetate (PredForte) eye drops. It aims to show that Dextenza can effectively reduce post-surgery inflammation without being inferior to the usual eyedrop regimen.

What are the potential side effects?

Dextenza may cause side effects similar to other steroid treatments such as increased pressure inside the eye, cataract formation, delayed healing or infections of the eye. However, specific side effects will be monitored throughout this study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I need general anesthesia for my procedure.

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I am 13 or older with worsening keratoconus and scheduled for a specific corneal treatment.

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My keratoconus is getting worse, shown by changes in my eye shape or vision.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My nasolacrimal duct size is either below 0.4 mm or at least 1.0 mm.

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I have had acute hydrops in my treated eye.

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I do not have narrowing in the area where the device will be placed.

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I have or am being treated for glaucoma or high eye pressure.

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I have had eye inflammation or infection before in the eye that was treated.

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I am receiving treatment that affects my immune system in my eye(s).

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I have had glaucoma in the eye that is being treated.

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My tear duct in the study eye is blocked.

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I am currently taking immunosuppressants or oral steroids.

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I have severe scarring on my eye from before.

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I do not have an active infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months (180 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months (180 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months (180 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Corneal haze

Corneal re-epithelialization

Infection

+1 more

Secondary study objectives

Anterior segment OCT

Best Corrected Visual Acuity

Comfort

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Dextenza insertExperimental Treatment1 Intervention

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.

Group II: topical prednisolone acetate 1% (PredForte) eye dropsActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dextenza 0.4Mg Ophthalmic Insert

2020

Completed Phase 4

~210

0 / 14Eligibility criteria met