Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease (DEcIDED)

Study Overview
=================
Brief Summary
-----------------
This prospective, single-center, randomized, double-masked, parallel comparison, sponsored study seeks to investigate the efficacy of Intracanalicular dexamethasone Insert (IDI) on ameliorating the signs and symptoms of dry eye disease.

Official Title
-----------------
Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Drug: Dextenza (IDI) (Sustained Release Dexamethasone), (0.4 mg)
* Other: ProLong™ collagen plugs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Dry Eye Disease Objective Signs (Schirmer's II test <10 mm at 5 min; Tear Break-Up time (TBUT) of <10 seconds in 1 eye; corneal fluorescein staining of .=4 in at least 1 eye; conjunctival lissamine green staining of the nasal and temporal conjunctive >=4 in at least 1 eye) Ocular inflammation presence confirmed by In-Vivo Confocal Microscopy Exclusion Criteria: History of Diabetes History of ocular surgery, corneal infection, or corneal injury within the last 3 months Active ocular allergies Active ocular infection Allergic to benzalkonium chloride

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dextenza (IDI) (Sustained Release Dexamethasone, (0.4 mg)<br>intracanalicular dexamethasone insert | Drug: Dextenza (IDI) (Sustained Release Dexamethasone), (0.4 mg)<br>* Intracanalicular dexamethasone insert contains 0.4 mg dexamethasone and is designed to provide a sustained and tapered release of therapeutic levels of dexamethasone to the ocular surface for up to 30 days for the reduction of postsurgical inflammation and pain associated with ocular surgery.<br>|
| Placebo Comparator: ProLong™ collagen plugs<br>collagen plug | Other: ProLong™ collagen plugs<br>* The long term synthetic punctal plug is composed of an absorbable copolymer material and measures 0.4mm in diameter and 2.0mm in length.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ocular inflammation | As measured by change to dendritic cell density and ocular redness | Change from Baseline one month after intracanalicular insert implantation or punctal plug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Parameter: Ocular Surface Disease Index (OSDI) | 12-item scale; score ranges from 0 to 100 and is calculated by the sum of the scores for all 12 questions answered multiplied by 100, which is divided by the total number of questions answered times four | Change from Baseline one month after intracanalicular insert implantation or punctal plug | 
| Clinical Parameter: Ocular Pain Assessment Survey (OPAS) | 32-questions, 8-domain questionnaire using numerical rating scales to assess eye pain intensity (worse eye) in the past 24 hours and 2 weeks (worst, least and average pain intensity), frequency of eye and non-eye pain (past 24 hours and 2 weeks), non-eye pain intensity (past 24 hours and 2 weeks), impact on QoL, pre-occupation with eye and non-eye pain, aggravating factors and associated factors.) | Change from Baseline one month after intracanalicular insert implantation or punctal plug | 
| Clinical Parameter: Symptom Assessment in Dry Eye scores (SANDE) | Score is calculated by multiplying the frequency of symptoms score with the severity of symptoms score and obtaining the square root. | Change from Baseline one month after intracanalicular insert implantation or punctal plug | 
| Clinical Parameter: Tear Break Up Time (TBUT) | The standard TBUT measurement will be performed by dropping a fluorescein drop to the inferior tarsal conjunctiva and waiting 30 seconds. After several blinks, the tear film will be examined. The time lapse between the last blink and the appearance of the first randomly distributed dark discontinuity in the fluorescein stained tear film will be measured three times and the mean value of the measurements will be calculated. | Change from Baseline one month after intracanalicular insert implantation or punctal plug | 
| Clinical Parameter: Conjunctival staining | Grading of conjunctival lissamine green staining will be performed after 1 minutes of application of a lissamine green drop. Staining will be graded using the National Eye Institute (NEI) grading scheme, with a total range of 0-18. | Change from Baseline one month after intracanalicular insert implantation or punctal plug | 
| Clinical Parameter: Corneal staining with fluorescein | Corneal fluorescein staining will be performed after 2 minutes of application of a fluorescein drop. Staining will be graded using the National Eye Institute (NEI) grading scheme, with a total range of 0-15. | Change from Baseline one month after intracanalicular insert implantation or punctal plug | 
| Clinical Parameter: Schirmer II test | Aqueous tear production will be measured by the length in millimeters that the strip wets during 5 minutes. | Change from Baseline one month after intracanalicular insert implantation or punctal plug |