DEXTENZA for the Treatment of Pain and Inflammation Following Surgical Trabeculectomy and Ahmed Valve Procedures

Study Overview
=================
Brief Summary
-----------------
This is a prospective, comparative, open-label, single-center, randomized, investigator-sponsored clinical study and seeks to investigate clinical outcomes with standard of care and high dose DEXTENZA treatment compared to standard of care topical dexamethasone in patients undergoing trabeculectomy, trabeculectomy Ex-PRESS, Xen Gel stent, and Ahmed Valve surgery. Patients will be followed through 6 months. After screening a given patient for inclusion and exclusion criteria, and gaining informed consent, eyes of n=30 patients will be randomized to one of the following two groups (n=15per group) and followed from Baseline through Month 6.

Official Title
-----------------
DEXTENZA for the Treatment of Pain and Inflammation Following Surgical Trabeculectomy and Ahmed Valve Procedures

Conditions
-----------------
Glaucoma Following Surgery

Intervention / Treatment
-----------------
* Drug: DEXTENZA
* Drug: Topical Dexamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to provide signed written consent prior to participation in any study-related procedures Patient is diagnosed with glaucoma and undergoing trabeculectomy, trabeculectomy Ex-PRESS, Xen Gel stent, or Ahmed Valve surgery Exclusion Criteria: Have used topical corticosteroid treatment up to 48 hours prior to the baseline visit Have used oral corticosteroid within the past 14 days prior to baseline visit (Patients using stable doses of inhaled corticosteroids for 30 days prior to baseline visit can be included in the study) Have received intravitreal or sub-Tenon corticosteroid treatment prior to baseline visit or Ozurdex ® in the study eye within the 6 months prior to the baseline visit Are currently using prescribed nonsteroidal anti-inflammatory agents or prescribed immunosuppressive agents, unless the dose has been stable for the last 6 weeks and no change in dosing is anticipated for the duration of the study Are pregnant or lactating female, or female of childbearing age using inadequate birth control method Have participated in another investigational device or drug study within 30 days of the baseline visit Anterior chamber cells present at time of enrollment Known allergy to dexamethasone or prednisolone

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

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

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>a single intracanalicular dexamethasone (0.4 mg) insert | Drug: DEXTENZA<br>* Intracanalicular Dexamethasone ophthalmic insert (0.4mg)<br>* Other names: Dexamethasone (0.4mg) Insert;|
| Active Comparator: Topical Dexamethasone Treatment<br>Standard of care topical dexamethasone treatment through Month 2 dosing and tapering following: 6x/day week 1 4x/day weeks 2-4 2x/day weeks 5-8 Day of surgery dexamethasone ointment and patch will be applied post-surgically for overnight treatment and removed at post-operative day 1 visit in Group B eyes. | Drug: Topical Dexamethasone<br>* topical dexamethasone drops<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in intraocular pressure (IOP) | mean change in intraocular pressure (IOP) from day of surgery and proportion of eyes requiring additional topical dexamethasone or anti-metabolite therapy over time | From baseline through month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in best corrected visual acuity (BCVA) | Mean change in BCVA using Snellen eye charts | From baseline through month 6 | 
| Mean change in Visual Field (MD) | Mean change in Visual Field (MD) will be detected using a perimeter device. The patient looks into the perimeter at a center target. Only one eye is tested at a time. The eye not being tested is covered with an eye patch. Small, dim lights will flash in the device and the patient will press a button each time they see the light. The results will show if the patient has had any changes in their visual field. | From baseline through month 6 | 
| Conjunctival healing outcomes as defined by proportion of eyes requiring needling intervention associated with scar/fibrin development | Conjunctival healing outcomes as defined by proportion of eyes requiring needling intervention associated with scar/fibrin development | From baseline through month 6 | 
| Proportion of eyes with absence of anterior chamber (AC) cells (score of 0) as measured by the Standardization of Uveitis Nomenclature (SUN) scale | Proportion of eyes with absence of anterior chamber (AC) cells (score of 0) as measured by the Standardization of Uveitis Nomenclature (SUN) scale | From baseline through month 6 | 
| Time to resolution of anterior chamber (AC) cells and/or AC flare | Time to resolution of anterior chamber (AC) cells and/or AC flare | From baseline through month 6 | 
| Proportion of eyes with absence of pain as measured by pain scale of 1-10 (pain score of 0 = absence) | Proportion of eyes with absence of pain as measured by pain scale of 1-10 (pain score of 0 = absence) | From baseline through month 6 | 
| Number of patient call backs to medical staff regarding post-operative management of pain or medication management/dosing inquiry as documented by Electronic Health Record (E.H.R.). | Number of patient call backs to medical staff regarding post-operative management of pain or medication management/dosing inquiry as documented by Electronic Health Record (E.H.R.). | From baseline through month 6 | 
| Incidence and severity of adverse events | Incidence and severity of adverse events | From baseline through month 6 |