Lipiflow Treatment Alone vs. Lipiflow + Dextenza Treatment for Dry Eye Disease

NCT04413279 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-04-18

No results posted yet for this study

Summary

To evaluate the benefit of treatment with a physician administered intracanalicular dexamethasone insert in evaporative dry eye disease (DED) patients with meibomian gland disfunction (MGD) and underlying inflammation undergoing LipiFlow Thermal Pulsation.

Conditions

  • Dry Eye Syndromes

Interventions

PROCEDURE

LipiFlow Thermal Pulsation

To manage patients with dry eye disease secondary to MGD

DRUG

Dexamethasone Intracanalicular Insert, 0.4mg with LipiFlow Thermal Pulsation

to investigate the benefit of managing patients with DED secondary to MGD with a sustained release intracanalicular dexamethasone (0.4 mg) insert in addition to LipiFlow Thermal Pulsation

Sponsors & Collaborators

  • Ocular Therapeutix, Inc.

    collaborator INDUSTRY
  • Eye Surgeons of Indiana

    lead NETWORK

Principal Investigators

  • Damon Dierker, OD, FAAO · Eye Surgeons of Indiana

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2021-07-01
Completion
2021-07-01
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 NCT04413279 on ClinicalTrials.gov