← Back to Search

Corticosteroid

Dextenza insert 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months (180 days)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I need general anesthesia for my procedure.

Select...

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Corneal haze

Corneal re-epithelialization

Infection

+1 more

Secondary outcome measures

Anterior segment OCT

Best Corrected Visual Acuity

Comfort

+4 more

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Maanasa Indaram, MDLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age limit for participants in this medical study set at 80 years or younger?

"To be eligible for this research study, individuals must meet the age requirements which specify a minimum of 13 years old and a maximum of 64 years old."

Answered by AI

Are patients currently able to enroll in this ongoing study?

"According to the information available on clinicaltrials.gov, this specific clinical trial is currently not actively seeking participants. The study was initially posted on January 1st, 2024 and last updated on January 23rd, 2024. However, it's important to note that there are still numerous other ongoing trials accepting participants at this time—approximately 45 in total."

Answered by AI

What are the criteria for individuals who may qualify to participate in this research?

"To be eligible for participation in this clinical trial, individuals must have a diagnosed case of keratoconus and fall within the age range of 13 to 64 years old. The study aims to enroll a total of 20 participants."

Answered by AI

What are the anticipated results that researchers hope to achieve through this experimental investigation?

"The primary objective of this study, which will be assessed over a period of approximately 6 months (180 days), is to evaluate the effectiveness in preventing infection. The secondary objectives include assessing ease of insertion using a scale from 0-5 (with 0 indicating easy insertion and 5 indicating difficult insertion) as reported by physicians, measuring changes in anterior segment OCT findings compared to baseline, and determining changes in best-corrected visual acuity compared to baseline as measured through day 180 with the use of dexamethasone intracanalicular insert."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dextenza for Corneal Crosslinking

Maanasa Indaram, MD 2024. "Dextenza for Corneal Crosslinking". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06235567.

All > Keratoconus