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

Intracanalicular Dexamethasone Used in Conjunction With LipiFlow for the Treatment of Meibomian Gland Dysfunction in Patients With Evaporative Dry Eye Disease and Evidence of Clinically Significant Inflammation

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Procedure: LipiFlow Thermal Pulsation; Drug: Dexamethasone Intracanalicular Insert, 0.4mg with LipiFlow Thermal Pulsation

Detailed Description

This prospective, open-label, single-center, non-randomized, investigator-sponsored clinical study seeks 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 compared to LipiFlow Thermal Pulsation alone. In addition, this study will evaluate the ease of Dextenza insertion and the patient preference for therapy.

After screening a given patient for inclusion and exclusion criteria, and gaining informed consent, each eye will undergo LipiFlow Thermal Pulsation on the same day. The most symptomatic eye will be selected to receive DEXTENZA® insertion on the day of the procedure (study eye), while the other eye will be assigned to a receive a sham punctum dilation (control eye). If there is no obvious symptomatic difference, the right eye will receive the intracanalicular insert. Per patient, the study period will last for approximately 12 weeks after the LipiFlow procedure, consisting of one screening visit, one treatment v4isit and 3 post-procedure follow-up visits (week 1, week 4 and week 12). At week 1, week 4 and week 12, primary and secondary endpoints will be assessed alongside standard-of-care procedures. Adjusting for enrollment period, the study will last a total of approximately 4 months.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46040
      • Eye Surgeons of Indiana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

A patient's study eye must meet the following criteria to be eligible for inclusion in the study:

• 18 years of age or older
• Evaporative DED with MGD and clinically significant inflammation
• Willing and able to comply with clinic visits and study related procedures
• Willing and able to sign the informed consent form

Exclusion Criteria:

A patient who meets any of the following criteria will be excluded from the study:

• Patients under the age of 18.
• Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
• Active infectious systemic disease
• Active infectious ocular or extraocular disease
• Altered nasolacrimal flow of either acquired, induced, or congenital origin
• Hypersensitivity to dexamethasone
• Patient being treated with either topical, oral, or intravenous steroids
• Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lipiflow Only Group; Patients with dry eye disease Lipiflow only	Procedure: LipiFlow Thermal Pulsation; To manage patients with dry eye disease secondary to MGD
Experimental: Lipiflow + Dextenza Group; Patients with dry eye disease Lipiflow + Dextenza	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; Other Names: Dextenza

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in meibomian gland scores (expressibility and quality)	As measured on a grading scale 1 to 4 and graded by the physician	Assessed at Baseline, Week 1, Week 4 and Week 12
Patient preference for	As measured by COMTOL Survey	Assessed at Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in MMP-9	As measured by InflammaDry	Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
Mean change in ocular surface staining	As measured by sodium fluorescein and lissamine green	Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
Mean change in tear break-up time (TBUT)	As measured by TBUT testing	Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
Mean change in tear osmolarity	As measured by TearLab	Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
Mean change in DEQ-5	As measured by DEQ-5 Questionnaire (Dry Eye Questionnaire. The DEQ-5 is comprised of 5 items: frequency of watery eyes, discomfort, and dryness (0-4 scale) and late day discomfort and dryness intensity (0-5 scale). Higher numbers indicate more severe symptoms.	Assessed at Baseline, Week 1, Week 4 and Week 12 Visit
Mean change in Best-corrected Visual Acuity (BCVA)	As measured by ETDRS chart	Assessed at Baseline, Week 1, Week 4 and Week 12 Visit

Collaborators and Investigators

• Sponsor: Eye Surgeons of Indiana
• Collaborators: Ocular Therapeutix, Inc.
• Investigators: Principal Investigator: Damon Dierker, OD, FAAO, Eye Surgeons of Indiana

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: May 28, 2020
• First Submitted That Met QC Criteria: May 28, 2020
• First Posted (Actual): June 2, 2020

Study Record Updates

• Last Update Posted (Actual): April 18, 2022
• Last Update Submitted That Met QC Criteria: April 11, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: The DIERKER Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No