Dextenza With ILUX for Treatment of MGD

Warrenville Eyecare30 enrolled

Overview

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.

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Meibomian Gland Dysfunction Evaporative Dry Eye

Interventions

Dexamethasone, 0.4mgDRUG

iLUX + dextenza

Prednisone acetateDRUG

Prednisolone acetate 1% and iLux

ControlOTHER

iLUX alone.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Warrenville EyeCare & LASIK

Warrenville, Illinois, United States

Outcomes

Primary Outcomes

Change in Meibomian gland score (MGS)

Change from baseline in meibomian gland scores (expressibility and quality)

Time frame: Assessed on week 1, week 4 and week 12.

Patient satisfaction with treatment

preference for therapy as measured by COMTOL

Time frame: Assessed on week 12

Secondary Outcomes

Change in Matrix metalloproteinase (MMP) -9

Mean change in MMP-9 from baseline as measured by InflammaDry

Time frame: 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

Time frame: 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

Time frame: Assessed on week 1, week 4 and week 12

Change in Ocular Surface Disease Index (OSDI) score

Mean change in OSDI from baseline

Time frame: 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

Time frame: Assessed on week 1, week 4 and week 12

Physician Ease of Insertion of Dextenza

Data from ClinicalTrials.gov

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