Dextenza With ILUX for Treatment of MGD

Phase 4

Completed

• Conditions: Evaporative Dry Eye; Meibomian Gland Dysfunction
• Interventions: Drug: Dexamethasone, 0.4mg; Other: Control; Drug: Prednisone acetate

• Registration Number: NCT04658927
• Lead Sponsor: Warrenville Eyecare

Brief 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 iLUX MGD Treatment System.

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 Timeline

• Study First Submitted: 2020-11-18
• Study First Submitted QC: 2020-12-01
• Study First Posted: 2020-12-09
• Study Start: 2021-01-04
• Primary Completion: 2021-01-11
• Study Completion: 2021-05-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-26
• Last Update Posted: 2022-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethosone intracanalicular insert	Dexamethasone, 0.4mg	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).
Group 2: Sham dilation	Control	15 fellow eye will undergo ILux and receive punctal "sham" dilation (control eye).
Group 1: Prednisolone actetate 1%	Prednisone acetate	15 fellow eye will undergo iLux and receive topical prednisolone acetate 1% on a 4,3,2,1 taper for 30 days.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Warrenville EyeCare & LASIK; 🇺🇸 Warrenville, Illinois, United States