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Safety and Efficacy of Dexamethasone Ophthalmic Insert (Dextenza®) in the Management of Clinically Significant Dry Eye

NCT04498468 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2024-03-15

Study results available
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Summary

To determine efficacy and safety profile of dexamethasone 0.4mg lacrimal insert in dry eye related ocular surface inflammation.

Conditions

  • Dry Eye

Interventions

DRUG

Sustained Release Dexamethasone, 0.4 mg

dexamethasone 0.4mg lacrimal insert

OTHER

E-Caprolactone-L-Lactide copolymer (PCL) punctal plug

Control eye will receive a tear duct plug without the dexamethasone (EXTENDED WEAR SYNTHETIC ABSORBABLE PUNCTAL PLUG made of E-Caprolactone-L-Lactide copolymer (PCL). Absorbs in 60 to 180 days. Size 0.5mm which is comparable to the study treatment)

Sponsors & Collaborators

Principal Investigators

  • Esen Akpek, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-16
Primary Completion
2023-03-03
Completion
2023-03-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04498468 on ClinicalTrials.gov