Dextenza With ILUX for Treatment of MGD

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Meibomian Gland Dysfunction, Evaporative Dry Eye

Intervention / Treatment
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* Drug: Dexamethasone, 0.4mg
* Drug: Prednisone acetate
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethosone intracanalicular insert<br>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<br>* iLUX + dextenza<br>* Other names: dextenza;|
| Active Comparator: Group 1: Prednisolone actetate 1%<br>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<br>* Prednisolone acetate 1% and iLux<br>|
| Sham Comparator: Group 2: Sham dilation<br>15 fellow eye will undergo ILux and receive punctal sham dilation (control eye). | Other: Control<br>* iLUX alone.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dry eye, meibomian gland dysfunction