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Corticosteroid
Safety and Efficacy of Dexamethasone Ophthalmic Insert (Dextenza®) in the Management of Clinically Significant Dry Eye
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
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial is testing a small, dissolvable insert that releases medication over time for people with significant dry eye. The insert aims to reduce inflammation and improve symptoms without the need for regular eye drops. It provides a steady release of medicine directly to the eye, making treatment easier and more comfortable. A dexamethasone-loaded nanowafer (Dex-NW) has been developed to release the drug on the ocular surface for a longer duration than traditional eye drops.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Efficacy Endpoint as Assessed by Dry Eye Sign Using Ocular Surface Scale (OSS)
Patient Reported Symptom
Secondary study objectives
Percentage of Subjects Achieving 2 Severity Grade Improvement in Corneal Staining
Percentage of Subjects Achieving Improvement in Their Most Bothersome Symptom
Other study objectives
Percentage of Participants With Intraocular Pressure Increase
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
2,332 Previous Clinical Trials
14,874,823 Total Patients Enrolled
Esen Akpek, MDPrincipal InvestigatorJohns Hopkins University
2 Previous Clinical Trials
102 Total Patients Enrolled