The study is being done to measure the absorption of the DEXTENZA implant and inflammation concentration levels in the eye.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
Dexamethasone ophthalmic insert 0.4 mg for intracanalicular use
Bucci Laser Vision
Wilkes-Barre, Pennsylvania, United States
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).
Time frame: 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).
Time frame: Measured 1-3 days, 6-8 days, 13-15 days, 19-23 days, and 26-31 days after Dextenza insertion
Correlation between dexamethasone levels and inflammatory cytokines
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
Time frame: 1-3 days, 6-8 days, 13-15 days, 19-23, or 26-31 days after Dextenza insertion
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