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Evaluation of Dextenza in Patients With Ocular GVHD and Effects on Ocular Surface Disease Outcomes

NCT04728646 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2022-01-05

No results posted yet for this study

Summary

To evaluate the safety and efficacy of Dextenza intracanalicular insert in patients with ocular graft-versus-host disease (GVHD).

Conditions

  • Graft Vs Host Disease

Interventions

DRUG

DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg, for intracanalicular use

Inserted During Screening/Baseline: Day Zero in either the right or left eye (depending on randomization)

DEVICE

Regular dissolvable intracanalicular plug

Inserted During Screening/Baseline: Day Zero in either the right or left eye (depending on randomization)

Sponsors & Collaborators

  • Ocular Therapeutix, Inc.

    collaborator INDUSTRY

  • Massachusetts Eye and Ear Infirmary

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2021-12-13
Completion
2021-12-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04728646 on ClinicalTrials.gov