Lipiflow Treatment Alone vs. Lipiflow + Dextenza Treatment for Dry Eye Disease

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 LipiFlow Thermal Pulsation.

Detailed Description
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This prospective, open-label, single-center, non-randomized, investigator-sponsored clinical study seeks to investigate the benefit of managing patients with DED secondary to MGD with a sustained release intracanalicular dexamethasone (0.4 mg) insert in addition to LipiFlow Thermal Pulsation compared to LipiFlow Thermal Pulsation alone. In addition, this study will evaluate the ease of Dextenza insertion and the patient preference for therapy. After screening a given patient for inclusion and exclusion criteria, and gaining informed consent, each eye will undergo LipiFlow Thermal Pulsation on the same day. The most symptomatic eye will be selected to receive DEXTENZA® insertion on the day of the procedure (study eye), while the other eye will be assigned to a receive a sham punctum dilation (control eye). If there is no obvious symptomatic difference, the right eye will receive the intracanalicular insert. Per patient, the study period will last for approximately 12 weeks after the LipiFlow procedure, consisting of one screening visit, one treatment v4isit and 3 post-procedure follow-up visits (week 1, week 4 and week 12). At week 1, week 4 and week 12, primary and secondary endpoints will be assessed alongside standard-of-care procedures. Adjusting for enrollment period, the study will last a total of approximately 4 months.

Official Title
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Intracanalicular Dexamethasone Used in Conjunction With LipiFlow for the Treatment of Meibomian Gland Dysfunction in Patients With Evaporative Dry Eye Disease and Evidence of Clinically Significant Inflammation

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Procedure: LipiFlow Thermal Pulsation
* Drug: Dexamethasone Intracanalicular Insert, 0.4mg with LipiFlow Thermal Pulsation


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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lipiflow Only Group<br>Patients with dry eye disease Lipiflow only | Procedure: LipiFlow Thermal Pulsation<br>* To manage patients with dry eye disease secondary to MGD<br>|
| Experimental: Lipiflow + Dextenza Group<br>Patients with dry eye disease Lipiflow + Dextenza | Drug: Dexamethasone Intracanalicular Insert, 0.4mg with LipiFlow Thermal Pulsation<br>* to investigate the benefit of managing patients with DED secondary to MGD with a sustained release intracanalicular dexamethasone (0.4 mg) insert in addition to LipiFlow Thermal Pulsation<br>* Other names: Dextenza;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in meibomian gland scores (expressibility and quality) | As measured on a grading scale 1 to 4 and graded by the physician | Assessed at Baseline, Week 1, Week 4 and Week 12 | 
| Patient preference for | As measured by COMTOL Survey | Assessed at Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in MMP-9 | As measured by InflammaDry | Assessed at Baseline, Week 1, Week 4 and Week 12 Visit | 
| Mean change in ocular surface staining | As measured by sodium fluorescein and lissamine green | Assessed at Baseline, Week 1, Week 4 and Week 12 Visit | 
| Mean change in tear break-up time (TBUT) | As measured by TBUT testing | Assessed at Baseline, Week 1, Week 4 and Week 12 Visit | 
| Mean change in tear osmolarity | As measured by TearLab | Assessed at Baseline, Week 1, Week 4 and Week 12 Visit | 
| Mean change in DEQ-5 | As measured by DEQ-5 Questionnaire (Dry Eye Questionnaire. The DEQ-5 is comprised of 5 items: frequency of watery eyes, discomfort, and dryness (0-4 scale) and late day discomfort and dryness intensity (0-5 scale). Higher numbers indicate more severe symptoms. | Assessed at Baseline, Week 1, Week 4 and Week 12 Visit | 
| Mean change in Best-corrected Visual Acuity (BCVA) | As measured by ETDRS chart | Assessed at Baseline, Week 1, Week 4 and Week 12 Visit |