Pharmacokinetics of Aqueous Dexamethasone

Study Overview
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Brief Summary
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The study is being done to measure the absorption of the DEXTENZA implant and inflammation concentration levels in the eye.

Official Title
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The Pharmacokinetics of Aqueous Dexamethasone and the Inflammatory Cytokine Response After Treatment With a Dexamethasone Intracanalicular Insert - The CYTODEX Study

Conditions
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Pharmacokinetics, Aqueous Dexamethasone, Inflammatory Cytokine Response

Intervention / Treatment
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* Drug: Dexamethasone Ophthalmic implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male of female, aged 55 or older Scheduled to undergo phacoemulsification with the intraocular lens (IOL) implantation for the treatment of cataract Willing to comply with study instructions, agree to make study appointments, and complete the course of the study Must sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate Exclusion Criteria: Known allergy or contraindication to the test article or its components Presence of any ocular abnormality or significant illness that, in the investigator's opinion, could affect the subject's health History of any illness that could be expected to interfere with the study Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or study May not be currently using topical or systemic steroids or NSAIDs during the course of the study or within 4 weeks prior to enrolling in the study other than Dextenza and Omidria Subject has active corneal, conjunctival, or canalicular infections, including: Epithelial herpes simplex keratitis (dendritic keratitis) Vaccini Varicella Mycobacterial infections Fungal diseases of the eye Dacryocystitis

Ages Eligible for Study
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Minimum Age: 55 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dextenza (Group A)<br>Dextenza (dexamethasone ophthalmic insert 0.4mg) 1-3 days prior to cataract surgery | Drug: Dexamethasone Ophthalmic implant<br>* Dexamethasone ophthalmic insert 0.4 mg for intracanalicular use<br>|
| Experimental: Dextenza (Group B)<br>Dextenza (dexamethasone ophthalmic insert 0.4mg) 6-8 days prior to surgery | Drug: Dexamethasone Ophthalmic implant<br>* Dexamethasone ophthalmic insert 0.4 mg for intracanalicular use<br>|
| Experimental: Dextenza (Group C)<br>Dextenza (dexamethasone ophthalmic insert 0.4mg) 13-15 days prior to surgery | Drug: Dexamethasone Ophthalmic implant<br>* Dexamethasone ophthalmic insert 0.4 mg for intracanalicular use<br>|
| Experimental: Dextenza (Group D)<br>Dextenza (dexamethasone ophthalmic insert 0.4mg) 19-23days prior to surgery | Drug: Dexamethasone Ophthalmic implant<br>* Dexamethasone ophthalmic insert 0.4 mg for intracanalicular use<br>|
| Experimental: Dextenza (Group E)<br>Dextenza (dexamethasone ophthalmic insert 0.4mg) 26-31 days prior to surgery | Drug: Dexamethasone Ophthalmic implant<br>* Dexamethasone ophthalmic insert 0.4 mg for intracanalicular use<br>|
| No Intervention: Control<br>Will not receive Dextenza (dexamethasone ophthalmic insert 0.4mg) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics in Aqueous Humor Samples | Concentration of dexamethasone in the aqueous humor will be determined by an independent laboratory using standardized high-pressure liquid chromatography and mass spectrometry assasys. Pharmacokinetic parameters determined from aqueous humor concentration will minimally include maximum concentration (Cmax). | Measured 1-3 days, 6-8 days, 13-15 days, 19-23 days, and 26-31 days after Dextenza insertion | 
| Pharmacokinetics in Aqueous Humor Samples | Concentration of inflammatory cytokines (IL-1 beta, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p70), IL-13, TNF alpha, and IFN gamma) in the aqueous humor will be determined by an independent laboratory using standardized high-pressure liquid chromatography and mass spectrometry assasys. Pharmacokinetic parameters determined from aqueous humor concentration will minimally include maximum concentration (Cmax). | Measured 1-3 days, 6-8 days, 13-15 days, 19-23 days, and 26-31 days after Dextenza insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between dexamethasone levels and inflammatory cytokines | Test for statistically significant correlations between the aqueous concentrations of dexamethasone and inflammatory cytokines (IL-1 beta, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p70), IL-13, TNF alpha, and IFN gamma) over time | 1-3 days, 6-8 days, 13-15 days, 19-23, or 26-31 days after Dextenza insertion |