Efficacy of Dextenza Insert in Upper vs Lower Punctum Following Cataract Surgery With PCIOL.

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) with or without iStent/Hydrus/Goniotomy when placed in the lower punctum compared to the upper punctum.

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) with or without iStent/Hydrus/Goniotomy when placed in the lower punctum compared to the upper punctum.

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).

Conditions
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Cataract

Intervention / Treatment
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* Drug: Dextenza 0.4Mg Ophthalmic Insert


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects will be eligible for study participation if they: Are planning to undergo non-complicated CCI CE/PCIOL in one or both eyes with or without iStent/Hydrus/Goniotomy. Are willing and able to comply with clinic visits and study related procedures. Are willing and able to sign the informed consent form. Not pregnant. Exclusion Criteria: Subjects are not eligible for study participation if they: 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. Have active infectious systemic disease. Have active infectious ocular or extraocular disease. Have unobstructed nasolacrimal duct in the study eye(s) (dacrocystitis). 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 an/or oral steroids. Are Pregnant or breast-feeding or wish to become pregnant during the length of study participation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Each subject's participation is expected to last for approximately 1 month and will be required to complete six scheduled visits over the course of the study period: Baseline (Screening Visit), Operative Visit/Insertion Day (Day 0), Day 1, Day 8, Day 14 and Day 30.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lower Punctum Insertion (Group 1)<br>DEXTENZA (dexamethasone ophthalmic insert, 0.4mg) for intracanalicular use Group 1 (up to 40 eyes) will receive the insert in the lower punctum on the day of surgery in the OR. | Drug: Dextenza 0.4Mg Ophthalmic Insert<br>* (dexamethasone ophthalmic insert)-for the treatment of ocular inflammation and pain following following ophthalmic surgery.<br>|
| Other: Upper Punctum Insertion (Group 2)<br>DEXTENZA (dexamethasone ophthalmic insert, 0.4mg) for intracanalicular use Group 2 (up to 40 eyes) will receive the insert in the upper punctum on the of surgery in the OR. | Drug: Dextenza 0.4Mg Ophthalmic Insert<br>* (dexamethasone ophthalmic insert)-for the treatment of ocular inflammation and pain following following ophthalmic surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants With Complete Absence of Ocular Pain at Day 8 | Participant reported ocular pain on a scale of (0-10) with zero (0) equaling no pain and ten(10) equaling maximal pain on day 8. | at Day 8 | 
| Participants With Zero Cells on Day 14 | Proportion of of participants with complete absence of anterior chamber cell at Day 14 as measured by Summed Ocular Inflammation Score (0-4). | at Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of Insertion | Rated as Easy, Moderate, Difficult | Day 0 | 
| Attempts to Achieve Successful Insertion | Number of attempts to insert the dexamethasone insert in the upper or lower punctum. | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCIOL, CCI CE