Pharmacokinetics of Aqueous Dexamethasone

Pharmacokinetics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04667507
• Other study ID #: IIT-CYTODEX
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: January 1, 2021
• Est. completion date: January 2023

Study information

• Verified date: October 2022
• Source: Bucci Laser Vision Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 102
• Est. completion date: January 2023
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aqueous Dexamethasone
• Inflammatory Cytokine Response
• Pharmacokinetics

Intervention

Drug:
• Dexamethasone Ophthalmic implant
Dexamethasone ophthalmic insert 0.4 mg for intracanalicular use

Locations

Country	Name	City	State
United States	Bucci Laser Vision	Wilkes-Barre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Frank A. Bucci, Jr., M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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