Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery

Study Overview
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Brief Summary
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Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery

Detailed Description
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Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt Treating Pain, and inflamMation Following Cataract Surgery Compared to Topical Prednisolone Acetate 1%.

Official Title
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Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt in Conjunction With Topical Drop Regimen Treating Pain and inflamMation Following Cataract Surgery Compared to SOC Topical Drop Regimen

Conditions
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Corneal Edema, Corneal Defect, Anterior Chamber Inflammation, Ocular Pain, Corneal Staining, Visual Outcome, CME - Cystoid Macular Edema

Intervention / Treatment
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* Drug: Dextenza 0.4Mg Ophthalmic Insert
* Drug: Prednisolone Acetate 1% Oph Susp
* Drug: Prolensa 0.07% Ophthalmic Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with clinically significant cataract and are planning to undergo non-complicated Clear Cornea Incision Cataract Extraction with Posterior Capsule IntraOcular Lens in one or both eyes Are willing and able to comply with clinic visits and study related procedures Are willing and able to sign the informed consent form Exclusion Criteria: Under the age of 18 at the time of signing the Informed Consent Form Pregnant or planning to become pregnant during the trial period Have visual acuity potential of less than 20/30 as recorded by a Retinal Acuity Meter or Potential Acuity Meter glare testing Have active infectious systemic disease Have active infectious ocular or extraocular disease Have punctal plug in the study eye Have obstructed nasolacrimal duct in the study eye(s) (dacryocystitus) Have known hypersensitivity to dexamethasone or are a known steroid responder Have a history of ocular inflammation or macular edema Has history of Laser Vision Correction (LASIK, PhotoRefractive Keratectomy) in the operated eye Are currently being treated with immunomodulating agents in the study eye Are currently being treated with immunosuppressants and/or oral steroids Are currently being treated with corticosteroid implant (i.e Ozurdex) Have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye Have a history of complete punctal occlusion in one or both punctum Currently using topical ophthalmic steroid medications Are unwilling or unable to comply with the study protocol Are determined by the Investigator to not be included for reasons not already specified (e.g., systemic, behavioral, or other ocular disease/abnormality) if the health of the subject or the validity of the study outcomes may be compromised by the subject's enrollment

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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No

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
Interventional Model Description: In patient who undergo cataract surgery, subjects will be randomized to 2 arms and be followed for a period of 3 months. Arm 1- control group, 50 subjects will receive Prednisolone Acetate 1% QID x 2 weeks then BID x 2 weeks. Arm 2 - study group, 50 subjects will receive Dextenza 0.4mg insert
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1 - Cataract surgery gtt regimen per SOC<br>Following cataract surgery (without Dextenza 0.4mg insert) patients will receive: Prednisolone Acetate 1% QID X 2 Weeks, then BID x 2 weeks and stop / Prolensa 0.07% QD X 4 Weeks and stop. | Drug: Prednisolone Acetate 1% Oph Susp<br>* Prednisolone Acetate 1% is a corticosteroid (to decrease inflammation) and being used as a topical drop after cataract surgery per Standard Of Care.<br>Drug: Prolensa 0.07% Ophthalmic Solution<br>* Prolensa 0.07% is a NSAID (to decrease inflammation, swelling and pain) and is being used as a topical drop after cataract surgery per Standard Of Care.<br>|
| Experimental: Arm 2 - Cataract surgery with Dextenza and less frequency of gtt regimen<br>Following cataract surgery with DEXTENZA 0.4mg insert, patients will receive: Prolensa 0.07% QD X 4 Weeks and stop | Drug: Dextenza 0.4Mg Ophthalmic Insert<br>* DEXTENZA 0.4Mg Ophthalmic Insert is a corticosteroid (to decrease inflammation) intracanalicular insert placed in the punctum, a natural opening in the eye lid, and into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives.<br>* Other names: Dexamethasone 0.4mg;Drug: Prolensa 0.07% Ophthalmic Solution<br>* Prolensa 0.07% is a NSAID (to decrease inflammation, swelling and pain) and is being used as a topical drop after cataract surgery per Standard Of Care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in anterior chamber inflammation (Cell and Flare) scores | Measured by SUN (Standardization on Uveitis Nomenclature) grading scale: absence of cell to be defined as a grade of 0-0.5 and absence of flare to be defined as a grade of: 0-1. 0-4 score scale, higher scores (4) mean a worse outcome. | Assessed on Days 1,7,30,90 | 
| Mean change in pain score | Measured with the visual analog scale (VAS); between 0 and 100; 0 meaning no pain and 100 meaning worst pain possible | Assessed on Day 1,7, 30 and 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual outcome (Best Corrected Visual Acuity) | Measured by ETDRS (Early Treatment Diabetic Retinopathy Study) chart. 0-70 letter read score. higher scores mean a better outcome. | Assessed on Day 1,7, 30 and 90 | 
| Absence of CME (Cystoid Macular Edema) | Measured by OCT (Optical Coherence Tomography) | Assessed on Day 90 | 
| Mean change in corneal staining | measured by the National Eye Institute 0-4 score scale, higher scores (4) mean a worse outcome. | Assessed on Day 7, 30 and 90 |