Xiidra vs. Xiidra + 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 patients with dry eye who are beginning treatment with Xiidra (lifitegrast ophthalmic solution) to reduce the signs and symptoms of dry eye disease.

Detailed Description
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This prospective study will use a fellow-eye design for 20 participants, 40 eyes. All eyes will receive bilateral Xiidra. The most symptomatic eye will be selected to receive DEXTENZA® insertion on the day Xiidra is prescribed (study eye), while the other eye will be assigned to receive sham punctum dilation (control eye). If there is no obvious symptomatic difference, the right eye will receive the intracanalicular insert. The study group will consist of 20 eyes receiving DEXTENZA® insertion. The control group will consist of 20 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 Xiidra (Lifitegrast Ophthalmic Solution) for the Treatment of Signs and Symptoms of Dry Eye Disease as Compared to Xiidra Alone

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Drug: Lifitegrast 5% Ophthalmic Solution
* Drug: Dexamethasone Intracanalicular Insert, 0.4mg with Lifitegrast 5% Ophthalmic Solution


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 Signs and symptoms of DED Consent to treat with topical immunomodulator 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 Patients who have been on topical immunomodulating agents in the previous 3 months to their baseline visit Patient being treated with either topical, oral, or intravenous immunosuppressive agents, immunomodulating agents, or steroid (including NSAIDS) 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: Xiidra Only Group<br>Patients with dry eye disease Xiidra only | Drug: Lifitegrast 5% Ophthalmic Solution<br>* To reduce signs and symptoms of dry eye disease<br>* Other names: Xiidra;|
| Experimental: Xiidra + Dextenza Group<br>Patients with dry eye disease Xiidra + Dextenza | Drug: Dexamethasone Intracanalicular Insert, 0.4mg with Lifitegrast 5% Ophthalmic Solution<br>* To determine the outcomes of reduction of signs and symptoms of dry eye disease with DEXTENZA as an added therapy, in addition to Xiidra therapy.<br>* Other names: Xiidra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in ocular surface staining | As measured by sodium fluorescein and lissamine green | Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit | 
| Patient Preference for therapy | As measured by COMTOL Survey | Assessed at Week 12 Visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in MMP-9 | As measure by InflammaDry | Assessed at Baseline, Week 1, Week 2, 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 2, Week 4 and Week 12 Visit | 
| Mean change in conjunctival injection | As measured on a scale of 0-4 and graded by the physician | Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit | 
| 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 2, Week 4 and Week 12 Visit | 
| Mean change in tear osmolarity | As measured by Tear Lab | Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit | 
| Mean change in DEQ-5 | As measured by the DEQ-5 Questionnaire | Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit | 
| Mean change in Best-corrected Visual Acuity (BCVA) | As measure by ETDRS | Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit |