The SITE Study - Dexamethasone Ophthalmic Insert In OR on Day of Surgery Versus In-office Post-Op Day 1

Study Overview
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Brief Summary
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To assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) compared to insertion 1-day post-op.

Detailed Description
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This is a randomized, controlled study to evaluate the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) compared to insertion 1-day post-op. There will be approximately 50 eyes with two groups: Group 1 (up to 10 eyes) will receive the insert in the lower punctum on the day of surgery in the OR. Group 2 (up to 40 eyes) will receive the insert in the lower punctum on the day after surgery in the HOPD. Each subject's participation is expected to last for approximately 1 month and will be required to complete five scheduled visits over the course of the study period: Baseline (Screening Visit), Operative Visit/Insertion Day (Day 0), Day 1, Day 7 and Day 30.

Official Title
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A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Treatment With an Intracanalicular Dexamethasone (0.4mg) Ophthalmic Insert in the Operating Room Following Cataract Surgery/Intraocular Lens Implant (IOL) Compared to Insertion 1-day Post-op - The SITE Study

Conditions
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Cataract

Intervention / Treatment
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* Drug: Dexamethasone 0.4 MG [Dextenza]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects will be eligible for study participation if they: Are an adult subject aged 65 years or older Are planning to undergo non-complicated CCI CE/PCIOL 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: Subjects are not eligible for study participation if they: Have active infectious systemic disease Have active infectious ocular or extraocular disease Have unobstructed nasolacrimal duct in the study eye(s) Have known hypersensitivity to dexamethasone or are a known steroid responder Have a history of ocular inflammation or macular edema Are currently being treated with immunomodulating agents in the study eye(s) 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 use 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) or 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: 65 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone Ophthalmic Insert Day of Surgery<br>Day of surgery, in OR placement | Drug: Dexamethasone 0.4 MG [Dextenza]<br>* Ophthalmic Intracanalicular Insert<br>* Other names: Dextenza;|
| Experimental: Dexamethasone Ophthalmic Insert Day 1 Post Op<br>Day 1 Post-Op, In-office (HOPD) | Drug: Dexamethasone 0.4 MG [Dextenza]<br>* Ophthalmic Intracanalicular Insert<br>* Other names: Dextenza;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior Chamber Cells | As measured by summed ocular inflammation score (0-4 with 4 meaning a worse outcome) | Assessed on Day 7 | 
| Ocular Pain | As measured by ocular pain assessment numerical grading scale (0-10 with 10 meaning a worse outcome) | Assessed on Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in BCVA | As measured by snellen VA | Assessed on Day -1, Day 7, Day 30 | 
| Percentage with complete absence of pain | As measured by ocular pain assessment numerical grading scale (0-10 with 10 meaning a worse outcome) | Assessed on Day -1, Day 1, Day 7, Day 30 | 
| Percentage with complete absence of cell | As measured by summed ocular inflammation score (0-4 with 4 meaning a worse outcome) | Assessed on Day -1, Day 1, Day 7, Day 30 | 
| Physician ease of insertion and visualization | As measured by physician questionnaire | Assessed on Day 1 |