DEXTENZA Therapy for Treatment of Allergic Conjunctivitis

Study Overview
=================
Brief Summary
-----------------
This prospective, open-label, single-center, randomized, investigator-sponsored clinical study seeks to compare patient-reported and clinical outcomes with DEXTENZA versus topical steroid or antihistamine treatment in patients with allergic conjunctivitis

Official Title
-----------------
DEXTENZA Versus Topical Steroid or Antihistamine Therapy for Treatment of Allergic Conjunctivitis

Conditions
-----------------
Bilateral Conjunctivitis (Disorder)

Intervention / Treatment
-----------------
* Drug: Dexamethasone ophthalmic insert 0.4Mg
* Drug: 0.2% loteprednol etabonate ophthalmic suspension
* Drug: olopatadine hydrochloride ophthalmic solution 0.7%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be at least 18 years of age Provide written informed consent and sign HIPAA form Be willing and able to follow all instructions and attend all study visits Be able and willing to discontinue wearing contact lenses throughout the study period Have a BCVA of ≥50 ETDRS letters (20/100 Snellen equivalent or better) in each eye as measured at Screening visit Have urine pregnancy testing for women considered capable of becoming pregnant; not be lactating; and agree to use a medically acceptable form of birth control throughout the study period Have a positive history of bilateral ocular allergies and a positive skin test reaction to a perennial allergen and a seasonal allergen as confirmed by the allergy testing at the Screening visit Exclusion Criteria: • Known contraindications or sensitivities to the use of any of the medications required per protocol, including known steroid responders Have any ocular condition that in the opinion of the Investigator could affect the subject's safety or study parameters (including, but not limited to uncontrolled narrow angle glaucoma, severe blepharitis, follicular conjunctivitis, iritis, pterygium, dry eye diagnosis, or active ocular infection) Have a known history of retinal detachment, diabetic retinopathy, or active retinal disease Use of systemic, inhaled, or nasal steroids Use of new systemic antihistamine use within 30 days of Screening visit Use of ocular or topical non-steroidal anti-inflammatory drugs (NSAIDs) Use of lid scrubs Use of decongestants Use of immunotherapeutic agents Use of monoamine oxidase inhibitors (MAOIs) Have a congenital or ocular anomaly or anomaly of the punctum that may preclude placement of DEXTENZA

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DEXTENZA<br>DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg, for intracanalicular use | Drug: Dexamethasone ophthalmic insert 0.4Mg<br>* Dextenza 0.4Mg Ophthalmic Insert<br>* Other names: Dextenza;|
| Active Comparator: Antihistamine<br>PAZEO (olopatadine hydrochloride ophthalmic solution) 0.7% for topical ophthalmic administration. | Drug: olopatadine hydrochloride ophthalmic solution 0.7%<br>* olopatadine hydrochloride ophthalmic solution 0.7%<br>* Other names: PAZEO;|
| Active Comparator: Topical Steroid<br>ALREX® (loteprednol etabonate ophthalmic suspension) contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. | Drug: 0.2% loteprednol etabonate ophthalmic suspension<br>* 0.2% loteprednol etabonate ophthalmic suspension<br>* Other names: ALREX;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported treatment preference of self-administered topical therapy versus physician-administered therapy at Day 30 (final visit) | Patient-reported treatment preference of self-administered topical therapy versus physician-administered therapy at Day 30 (final visit) | 30 days |