Pharmacokinetics of Aqueous Dexamethasone

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Pharmacokinetics; Aqueous Dexamethasone; Inflammatory Cytokine Response
• Intervention / Treatment: Drug: Dexamethasone Ophthalmic implant

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Wilkes-Barre, Pennsylvania, United States, 18702
      • Bucci Laser Vision

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Frank A. Bucci, Jr., M.D.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): October 31, 2021
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: September 21, 2020
• First Submitted That Met QC Criteria: December 8, 2020
• First Posted (Actual): December 14, 2020

Study Record Updates

• Last Update Posted (Actual): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: IIT-CYTODEX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes