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OpenTrials
Completed

NCT Number: NCT04667507

Pharmacokinetics of Aqueous Dexamethasone

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

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Key information

Conditions

Pharmacokinetics Aqueous Dexamethasone Inflammatory Cytokine Response

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bucci Laser Vision

Wilkes-Barre, Pennsylvania, 18702, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone Ophthalmic implant

Drug

Dexamethasone ophthalmic insert 0.4 mg for intracanalicular use

Primary outcomes

  1. Pharmacokinetics in Aqueous Humor Samples

    Time frame: Measured 1-3 days, 6-8 days, 13-15 days, 19-23 days, and 26-31 days after Dextenza insertion

    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).

  2. Pharmacokinetics in Aqueous Humor Samples

    Time frame: 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 outcomes

  1. Correlation between dexamethasone levels and inflammatory cytokines

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Frank A. Bucci, Jr., M.D.

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Dec 14, 2020
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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