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Corticosteroid

Intracanalicular Dexamethasone Insert for Dry Eye Syndrome (DEcIDED Trial)

Phase 4
Recruiting
Led By Pedram Hamrah, MD
Research Sponsored by Tufts Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of Dry Eye Disease
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline one month after intracanalicular insert implantation or punctal plug
Awards & highlights

DEcIDED Trial Summary

This trial is testing whether a dexamethasone insert can reduce symptoms of dry eye disease.

Who is the study for?
This trial is for individuals with Dry Eye Disease confirmed by specific tests and visible eye inflammation. It's not suitable for those who've had recent eye surgery, infections, injuries, diabetes, active ocular allergies or an allergy to benzalkonium chloride.Check my eligibility
What is being tested?
The study is testing the effectiveness of a Dexamethasone insert called Dextenza against ProLong™ collagen plugs in reducing symptoms of dry eye disease. Participants are randomly assigned to one of these treatments in a controlled environment.See study design
What are the potential side effects?
Dextenza may cause side effects like increased pressure inside the eye, discomfort at the insertion site, or possible risk of infection. Collagen plugs might lead to temporary irritation or excessive tearing.

DEcIDED Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with Dry Eye Disease.

DEcIDED Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline one month after intracanalicular insert implantation or punctal plug
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline one month after intracanalicular insert implantation or punctal plug for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in ocular inflammation
Secondary outcome measures
Clinical Parameter: Conjunctival staining
Clinical Parameter: Corneal staining with fluorescein
Clinical Parameter: Ocular Pain Assessment Survey (OPAS)
+4 more

DEcIDED Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Dextenza (IDI) (Sustained Release Dexamethasone, (0.4 mg)Active Control1 Intervention
intracanalicular dexamethasone insert
Group II: ProLong™ collagen plugsPlacebo Group1 Intervention
collagen plug

Find a Location

Who is running the clinical trial?

Tufts Medical CenterLead Sponsor
255 Previous Clinical Trials
255,214 Total Patients Enrolled
Ocular Therapeutix, Inc.Industry Sponsor
53 Previous Clinical Trials
5,523 Total Patients Enrolled
Pedram Hamrah, MDPrincipal InvestigatorTufts Medical Center
10 Previous Clinical Trials
1,800 Total Patients Enrolled

Media Library

Dextenza (IDI) (Sustained Release Dexamethasone) (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04527887 — Phase 4
Dry Eye Syndrome Research Study Groups: Dextenza (IDI) (Sustained Release Dexamethasone, (0.4 mg), ProLong™ collagen plugs
Dry Eye Syndrome Clinical Trial 2023: Dextenza (IDI) (Sustained Release Dexamethasone) Highlights & Side Effects. Trial Name: NCT04527887 — Phase 4
Dextenza (IDI) (Sustained Release Dexamethasone) (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04527887 — Phase 4
Dry Eye Syndrome Patient Testimony for trial: Trial Name: NCT04527887 — Phase 4

Frequently Asked Questions

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

Has the FDA sanctioned Dextenza (IDI) for sustained-release dexamethasone use (0.4 mg)?

"As this is a Phase 4 trial, meaning that the medication has already been approved, our team at Power assigned Dextenza (IDI) (Sustained Release Dexamethasone, (0.4 mg)) a rating of 3 on their safety scale."

Answered by AI

What is the usual purpose of administering Dextenza (IDI) (Sustained Release Dexamethasone, (0.4 mg)?

"Dextenza (IDI) (Sustained Release Dexamethasone, 0.4 mg), is commonly utilized to manage ophthalmia and sympathetic eye disorders. It can also be employed in the treatment of branch retinal vein occlusion as well as macular edema."

Answered by AI

What is the participant capacity for this clinical research?

"Yes, the clinicaltrials.gov listing for this trial affirms that it is still enrolling participants. First posted on September 4th 2020 and last edited July 11th 2022, 54 people are sought from 1 centre around the country."

Answered by AI

Are there any precedents of research into the extended-release version of Dexamethasone (0.4 mg) known as Dextenza (IDI)?

"Presently, there are 553 active trials for Dextenza (IDI) (Sustained Release Dexamethasone, (0.4 mg), with 144 of these located in the third phase of testing. Mishawaka Indiana is hosting most experiments for the drug, though across a total of 18618 locations research on this medication is being conducted."

Answered by AI

Is this experiment admitting new participants?

"Affirmative. According to the data hosted on clinicaltrials.gov, this medical experiment is currently accepting applicants. It was first posted on September 4th 2020 and has been revised as recently as July 11th 2022. 54 individuals will be accepted at a single research centre for participation in the trial."

Answered by AI

Who else is applying?

What state do they live in?
District of Columbia
Massachusetts
What site did they apply to?
Tufts Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I am willing to try new procedures to help with dry eye research.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease (DEcIDED)
2020. "Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease (DEcIDED)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04527887.
All > Dry Eye
~1 spots leftby Jun 2024
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