Pharmacokinetics of Aqueous Dexamethasone

Phase 4

Completed

• Conditions: Pharmacokinetics; Aqueous Dexamethasone; Inflammatory Cytokine Response
• Interventions: Drug: Dexamethasone Ophthalmic implant

• Registration Number: NCT04667507
• Lead Sponsor: Frank A. Bucci, Jr., M.D.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-21
• Study First Submitted QC: 2020-12-08
• Study First Posted: 2020-12-14
• Study Start: 2021-01-01
• Primary Completion: 2021-10-31
• Study Completion: 2022-06-22
• Status Verified: 2022-10
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dextenza (Group A)	Dexamethasone Ophthalmic implant	Dextenza (dexamethasone ophthalmic insert 0.4mg) 1-3 days prior to cataract surgery
Dextenza (Group B)	Dexamethasone Ophthalmic implant	Dextenza (dexamethasone ophthalmic insert 0.4mg) 6-8 days prior to surgery
Dextenza (Group D)	Dexamethasone Ophthalmic implant	Dextenza (dexamethasone ophthalmic insert 0.4mg) 19-23days prior to surgery
Dextenza (Group C)	Dexamethasone Ophthalmic implant	Dextenza (dexamethasone ophthalmic insert 0.4mg) 13-15 days prior to surgery
Dextenza (Group E)	Dexamethasone Ophthalmic implant	Dextenza (dexamethasone ophthalmic insert 0.4mg) 26-31 days prior to surgery

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics in Aqueous Humor Samples	Measured 1-3 days, 6-8 days, 13-15 days, 19-23 days, and 26-31 days after Dextenza insertion	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).

Secondary Outcome Measures

Name	Time	Method
Correlation between dexamethasone levels and inflammatory cytokines	1-3 days, 6-8 days, 13-15 days, 19-23, or 26-31 days after Dextenza insertion	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

Trial Locations

Locations (1)

Bucci Laser Vision; 🇺🇸 Wilkes-Barre, Pennsylvania, United States