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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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at day 30 and day 42

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)

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Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,274 Previous Clinical Trials

14,840,440 Total Patients Enrolled

Esen Akpek, MDPrincipal InvestigatorJohns Hopkins University

2 Previous Clinical Trials

102 Total Patients Enrolled

~18 spots leftby Jun 2025

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