Kinetics of hydrocortisone sodium phosphate penetration into the human
aqueous humor after topical application
Abstract
Aim of the study: Hydrocortisone is a soft steroid with low
anti-inflammatory properties and a short duration of action, used to
manage several ocular conditions. The clinical benefits and side effects
associated with hydrocortisone are well documented, but its basic
pharmacokinetic in the eye is yet to be fully elucidated. The purpose of
this study is to investigate the anterior chamber penetration
capabilities of hydrocortisone when used in different concentrations as
eye drops treatment. Materials and Methods: This is a double-blind,
single-center, randomized clinical trial performed at the Department of
Medicine and Surgery of the University of Perugia (Italy) on consecutive
patients who have undergone phacoemulsification with intraocular lens
implantation. Patients were randomly assigned on the morning of surgery
to receive a single instillation of 0.33% (group A) or 0.001% (group
B) hydrocortisone sodium phosphate solution. Group of patients C did not
receive any treatment and was used to measure the hydrocortisone
endogenous levels. Before surgery, one aliquot of aqueous humor for each
patient was aspirated. The time of collection for each sample was
recorded. Hydrocortisone concentrations were then stratified into six
interval classes of 30 minutes each. Results: The mean concentration of
hydrocortisone was significantly higher in group A (25.2±12.4 ng/ml)
compared with group B (7.11±1.51 ng/ml) and compared to the mean
hydrocortisone endogenous levels (3.92±1.18 ng/ml) (p<0.0001).
No statistically significant differences of hydrocortisone mean
concentrations between group B and the mean endogenous levels were
found. Conclusions: Considering the frequent need for prolonged topical
steroid therapies and the possible consequent undesirable side effects,
ophthalmologists should consider the lowest clinically effective dose of
hydrocortisone useful to obtain the desired therapeutic effect and in an
adequate time, to minimize the amount of steroids into the anterior
chamber and to avoid side effects, such as intraocular pressure increase
or cataract development.