ACCURATE Study for Subjects With Dry Eyes

Study Overview
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Brief Summary
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To determine treatment and imaging outcomes in bilateral ocular surface disease management with an intracanalicular dexamethasone (0.4 mg) insert compared to standard topical over-the-counter artificial tears lubrication management

Detailed Description
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This study will evaluate the benefit of treatment with a physician administered intracanalicular dexamethasone insert and patient administered artificial tears prn compared to patient administered artificial tears prn (control) in patients with bilateral ocular surface dry eye disease. The study is a self-controlled design and includes multiple objective, measureable, and quantifiable endpoints to best determine an objective response to treatment in patient eyes randomized to either the insert plus prn artificial tears or artificial tears prn control. To aid in ensuring best possible masking, DEXTENZA is best visualized with blue light and yellow filter and therefore visualization will not be assessed until final visit following all measures.

Official Title
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Randomized Self-Controlled Treatment With an Intracanalicular Dexamethasone Insert Compared to Topical Over the Counter Lubrication Therapy in Patients With Bilateral Ocular Surface Disease

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Drug: Dextenza 0.4Mg Intracanalicular Insert
* Other: Over the counter Artificial tears


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: Age 18 years and older Demonstrate objective signs of Ocular Surface Disease (OSD) or Demonstrate symptoms of OSD determined by a standardized questionnaire No other corneal pathology to create unknown variability Exclusion Criteria:A patient who meets any of the following criteria in either eye will be excluded from the study: History of using topical steroids or other anti-inflammatory drops within 6 months of the study History of corticosteroid implant (Ozurdex or Iluvien) or intravitreal steroid use for macular disease in last 12 months History or current use of oral steroids or immunosuppressants Active ocular infection History of HSV History corneal refractive surgery Uncontrolled Glaucoma

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dextenza<br>Treatment Arm-Dextenza insertion lower lid punctum at time of screening and use of OTC artificial tears as needed | Drug: Dextenza 0.4Mg Intracanalicular Insert<br>* all patients will receive Intracanalicular dexamethasone, 0.4mg insert lower punctum and able to use over the counter artificial tears PRN at patient discretion<br>* Other names: dexamethasone;|
| Active Comparator: Over the counter Artificial tears<br>Controlled arm: continuation of OTC artificial tears no placement of Dextenza intracanular insert | Other: Over the counter Artificial tears<br>* over the counter artificial tears PRN at patient discretion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine effect of dexamethasone insert over artificial tears | To determine the effect of dexamethasone insert plus over-the-counter artificial tears prn compared to over the counter artificial tears prn from Baseline at Week 2 (at 8 am, 12 pm and 4 pm) as measured by iTrace and IOL Master 700: and comfort of dry eyes using the OSDI scale and reading scores | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OSDI scores | comfort of dry eyes using the OSDI scale and reading scores, scores are from the SPEED questionnaire. scale from 0-3 0-Never 1- Sometime 2-Often 3-Constant for the symptoms | 1 month |