Pharmacokinetics of Aqueous Dexamethasone

Sponsor
Frank A. Bucci, Jr., M.D. (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04667507
Collaborator
(none)
102
1
6
9
11.4

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Dexamethasone Ophthalmic implant
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
102 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Pharmacokinetics of Aqueous Dexamethasone and the Inflammatory Cytokine Response After Treatment With a Dexamethasone Intracanalicular Insert - The CYTODEX Study
Actual Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Oct 1, 2021
Anticipated Study Completion Date :
Oct 1, 2021

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. 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 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 [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

  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]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bucci Laser Vision Wilkes-Barre Pennsylvania United States 18702

Sponsors and Collaborators

  • Frank A. Bucci, Jr., M.D.

Investigators

  • Principal Investigator: Frank A Bucci, Jr., MD, Bucci Laser Vision Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Frank A. Bucci, Jr., M.D., Medical Director, Bucci Laser Vision Institute
ClinicalTrials.gov Identifier:
NCT04667507
Other Study ID Numbers:
  • IIT-CYTODEX
First Posted:
Dec 14, 2020
Last Update Posted:
Sep 28, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 28, 2021