Clinical trial NCT04658927: Dextenza With ILUX for Treatment of MGD
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Meibomian Gland Dysfunction
Evaporative Dry Eye
Keywords: dry eye
meibomian gland dysfunction
Lead sponsor: Warrenville Eyecare
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All 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). There will be 2 groups:

Group 1: fellow eye will receive topical prednisolone acetate 1% on a 4,3,2,1 taper for 30 days (control eye) Group 2: fellow eye will receive punctal "sham" dilation (control eye).

If there is no obvious symptomatic difference, the right eye will receive the intracanalicular insert.

Screening Visit Treatment Visit 1 week follow up

1 month follow up 3 month follow up
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Meibomian gland score (MGS)
timeFrame: Assessed on week 1, week 4 and week 12.
measure: Patient satisfaction with treatment
timeFrame: Assessed on week 12
Secondary outcomes:
measure: Change in Matrix metalloproteinase (MMP) -9
timeFrame: Assessed on Week 1, 4, 12
measure: Change in corneal staining
timeFrame: Assessed on week 1, week 4 and week 12
measure: Change in tear osmolarity
timeFrame: Assessed on week 1, week 4 and week 12
measure: Change in Ocular Surface Disease Index (OSDI) score
timeFrame: Assessed on week 1, week 4 and week 12
measure: Change in best corrected visual acuity
timeFrame: Assessed on week 1, week 4 and week 12
measure: Physician Ease of Insertion of Dextenza
timeFrame: Assessed on day 1
Other outcomes:
Locations:
city: Warrenville
country: United States
facility: Warrenville EyeCare & LASIK
state: Illinois
Study officials:
References: