Aqueous Dexamethasone, Inflammatory Cytokine Response, Pharmacokinetics
Conditions
Brief summary
The study is being done to measure the absorption of the DEXTENZA implant and inflammation concentration levels in the eye.
Interventions
Dexamethasone ophthalmic insert 0.4 mg for intracanalicular use
Sponsors
Frank A. Bucci, Jr., M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed