Pharmacokinetics of Aqueous Dexamethasone

NCT04667507 | Completed Phase 4 FDA Drug

• 1 other identifier: IIT-CYTODEX
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pharmacokinetics; Aqueous Dexamethasone; Inflammatory Cytokine Response

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

Study Arms (6)

Dextenza (Group A)

EXPERIMENTAL

Dextenza (dexamethasone ophthalmic insert 0.4mg) 1-3 days prior to cataract surgery

Drug: Dexamethasone Ophthalmic implant

Dextenza (Group B)

EXPERIMENTAL

Dextenza (dexamethasone ophthalmic insert 0.4mg) 6-8 days prior to surgery

Drug: Dexamethasone Ophthalmic implant

Dextenza (Group C)

EXPERIMENTAL

Dextenza (dexamethasone ophthalmic insert 0.4mg) 13-15 days prior to surgery

Drug: Dexamethasone Ophthalmic implant

Dextenza (Group D)

EXPERIMENTAL

Dextenza (dexamethasone ophthalmic insert 0.4mg) 19-23days prior to surgery

Drug: Dexamethasone Ophthalmic implant

Dextenza (Group E)

EXPERIMENTAL

Dextenza (dexamethasone ophthalmic insert 0.4mg) 26-31 days prior to surgery

Drug: Dexamethasone Ophthalmic implant

Control

NO INTERVENTION

Will not receive Dextenza (dexamethasone ophthalmic insert 0.4mg)

Interventions

Dexamethasone Ophthalmic implant DRUG

Dexamethasone ophthalmic insert 0.4 mg for intracanalicular use

Dextenza (Group A); Dextenza (Group B); Dextenza (Group C); Dextenza (Group D); Dextenza (Group E)

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Frank A. Bucci, Jr., M.D.: lead

Study Sites (1)

Bucci Laser Vision

Wilkes-Barre, Pennsylvania, 18702, United States

Location

Study Officials

• Frank A Bucci, Jr., MD

  Bucci Laser Vision Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: December 14, 2020
• Study Start: January 1, 2021
• Primary Completion: October 31, 2021
• Study Completion: June 22, 2022
• Last Updated: October 21, 2024

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)