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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dextenza | Experimental | Treatment Arm-Dextenza insertion lower lid punctum at time of screening and use of OTC artificial tears as needed |
|
| Over the counter Artificial tears | Active Comparator | Controlled arm: continuation of OTC artificial tears no placement of Dextenza intracanular insert |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dextenza 0.4Mg Intracanalicular Insert | Drug | all patients will receive Intracanalicular dexamethasone, 0.4mg insert lower punctum and able to use over the counter artificial tears PRN at patient discretion |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| ITRACE | measured by iTrace to measure comfort of dry eyes, no scale just review the changes if there are any | 1 month |
| IOL Master | as measured by IOL Master 700 to measure comfort of dry eyes, compare the previous images after each visit |
Inclusion Criteria:A patient's study eye must meet the following criteria to be eligible for inclusion in the study:
Exclusion Criteria:A patient who meets any of the following criteria in either eye will be excluded from the study:
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| Name | Affiliation | Role |
|---|---|---|
| Inder P Singh, M.D. | President | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Eye Center of Racine | Racine | Wisconsin | 53405 | United States |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D002123 | Calcium Dobesilate |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
| Over the counter Artificial tears | Other | over the counter artificial tears PRN at patient discretion |
|
| 1 month |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |