Dextenza With ILUX for Treatment of MGD

Intracanalicular Dexamethasone Used in Conjunction With ILUX for the Treatment of Meibomian Gland Dysfunction (MGD) in Patients With Evaporative Dry Eye 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 iLUX MGD Treatment System.

Study Overview

• Status: Completed
• Conditions: Meibomian Gland Dysfunction; Evaporative Dry Eye
• Intervention / Treatment: Drug: Dexamethasone, 0.4mg; Drug: Prednisone acetate; Other: Control

Detailed Description

This prospective study will use a fellow-eye design for 30 participants, (2 groups of 15) equating to 60 eyes. All eyes will receive bilateral iLUX MGD Treatment System. The most symptomatic eye will be selected to receive DEXTENZA® insertion on the day of the procedure (study eye). In group 1, the other eye will be assigned to receive prednisolone acetate 1% on a 4,3,2,1 month taper schedule (active comparator). In group 2, the other eye will receive punctal "sham" dilation (control eye). If there is no obvious symptomatic difference, the right eye will receive the intracanalicular insert. The study group will consist of 30 eyes receiving DEXTENZA® insertion. The control group will consist of 15 eyes receiving prednisolone acetate 1% and 15 eyes receiving sham punctum dilation. Thus, for every eye in the study group, there will be a paired eye with similar baseline characteristics in the control group sourced from the same participant. This fellow-eye design allows for greater control of potential confounders tied to participants' systemic and ocular health.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Warrenville, Illinois, United States, 60555
      • Warrenville EyeCare & LASIK

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (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: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexamethosone intracanalicular insert; All 30 eyes will undergo iLUX MGD Treatment System for the treatment of evaporative DED secondary to MGD. Patients will have their most symptomatic eye selected to receive the dexamethasone intracanalicular insert at the day of the iLUX MGD Treatment System (study eye).	Drug: Dexamethasone, 0.4mg; iLUX + dextenza; Other Names: dextenza
Active Comparator: Group 1: Prednisolone actetate 1%; 15 fellow eye will undergo iLux and receive topical prednisolone acetate 1% on a 4,3,2,1 taper for 30 days.	Drug: Prednisone acetate; Prednisolone acetate 1% and iLux
Sham Comparator: Group 2: Sham dilation; 15 fellow eye will undergo ILux and receive punctal "sham" dilation (control eye).	Other: Control; iLUX alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Meibomian gland score (MGS)	Change from baseline in meibomian gland scores (expressibility and quality)	Assessed on week 1, week 4 and week 12.
Patient satisfaction with treatment	preference for therapy as measured by COMTOL	Assessed on week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Matrix metalloproteinase (MMP) -9	Mean change in MMP-9 from baseline as measured by InflammaDry	Assessed on Week 1, 4, 12
Change in corneal staining	Mean change in ocular surface staining (sodium fluorescein and lissamine green) from baseline as measured by the National Eye Institute grading scale	Assessed on week 1, week 4 and week 12
Change in tear osmolarity	Mean change in tear osmolarity from baseline as measured by Tear Lab	Assessed on week 1, week 4 and week 12
Change in Ocular Surface Disease Index (OSDI) score	Mean change in OSDI from baseline	Assessed on week 1, week 4 and week 12
Change in best corrected visual acuity	Mean change in Best-corrected Visual Acuity (BCVA) from baseline as measured by ETDRS chart	Assessed on week 1, week 4 and week 12
Physician Ease of Insertion of Dextenza	Physician ease of insertion as measured by a questionnaire	Assessed on day 1

Collaborators and Investigators

• Sponsor: Warrenville Eyecare

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Actual): January 11, 2021
• Study Completion (Actual): May 30, 2021

Study Registration Dates

• First Submitted: November 18, 2020
• First Submitted That Met QC Criteria: December 1, 2020
• First Posted (Actual): December 9, 2020

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: dry eye; meibomian gland dysfunction
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eyelid Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Meibomian Gland Dysfunction; 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; Prednisone
• Other Study ID Numbers: NIJM Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No