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Corticosteroid

Sustained Release Dexamethasone, 0.4 mg for Dry Eye Syndrome

Phase 4
Waitlist Available
Led By Esen Akpek, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to have a lacrimal plug placement into both lower puncta. If lower puncta are already plugged or cauterized/sealed, upper puncta will be used
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at day 30 and day 42
Awards & highlights

Study Summary

This trial is testing whether or not a dexamethasone 0.4mg lacrimal insert is effective and safe in treating dry eye related ocular surface inflammation.

Eligible Conditions
  • Dry Eye Syndrome

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You can have a small device placed in the inner corner of your lower eyelids to help with eye dryness. If the lower corner is already treated, the upper corner will be used instead.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 30 and day 42
This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 30 and day 42 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy Endpoint as Assessed by Dry Eye Sign Using Ocular Surface Scale (OSS)
Patient Reported Symptom
Secondary outcome measures
Percentage of Subjects Achieving 2 Severity Grade Improvement in Corneal Staining
Percentage of Subjects Achieving Improvement in Their Most Bothersome Symptom
Other outcome measures
Percentage of Participants With Intraocular Pressure Increase

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment ArmExperimental Treatment1 Intervention
Commercially available Sustained Release Dexamethasone, 0.4 mg intracannalicular insert (DEXTENZA® - Ocular Therapeutix, Bedford, MA)
Group II: Control ArmPlacebo Group1 Intervention
Commercially available EXTENDED WEAR SYNTHETIC ABSORBABLE PUNCTAL PLUG made of E-Caprolactone-L-Lactide copolymer (PCL) (Vera90™ - Elkridge, MD)

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,244 Previous Clinical Trials
14,816,789 Total Patients Enrolled
Esen Akpek, MDPrincipal InvestigatorJohns Hopkins University
2 Previous Clinical Trials
102 Total Patients Enrolled

Frequently Asked Questions

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

To what extent is the participation rate in this research project?

"Absolutely, the information posted on clinicaltrials.gov indicates that this examination is actively enrolling participants. This research project was initially advertised on March 16th 2021 and has been modified most recently in January 24th 2022. It needs 85 volunteers to be recruited at one medical centre."

Answered by AI

What health issues does Sustained Release Dexamethasone, 0.4 mg typically address?

"Sustained Release Dexamethasone, 0.4 mg has been given to patients for the treatment of ophthalmia and sympathetic conditions such as branch retinal vein occlusion, macular edema, and various other eye issues."

Answered by AI

Are there any prior investigations of Sustained Release Dexamethasone, 0.4 mg?

"Presently, 553 medical studies are assessing the efficacy of Sustained Release Dexamethasone, 0.4 mg with 144 trials in Phase 3. While a majority of these clinical tests take place in Mishawaka, Indiana , there are 18,618 sites globally running similar experiments for this drug."

Answered by AI

Has the Administration granted authorization to Sustained Release Dexamethasone, 0.4 mg?

"The safety rating for Sustained Release Dexamethasone, 0.4 mg is 3 on a scale of 1-3 due to it being in the final phase (Phase 4) and having been approved by regulatory agencies."

Answered by AI

Does this research initiative have any upper age restrictions?

"This clinical trial is including individuals who are of legal age and younger than a century."

Answered by AI

Is this research program still open for enrollment?

"Clinicaltrials.gov confirms that this medical experiment is open for recruitment, having been first published on March 16th 2021 and last edited on January 24th 2022."

Answered by AI

Does my profile meet the criteria for enrollment in this research?

"Participants need to meet two criteria in order to be accepted into this research: they must suffer from dry eyes, and be between 18 and 100 years of age. Currently 85 candidates are being enrolled for the trial."

Answered by AI

Who else is applying?

How old are they?
65+
What site did they apply to?
Wilmer Eye Institute, Johns Hopkins School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
~19 spots leftby Mar 2025