Long-Term Safety Of Loteprednol Etabonate 0.2% In The Treatment
Of Seasonal And Perennial Allergic Conjunctivitis
By Ilyas, H., et al,
Eye and Contact Lens, Vol. 30, 1, January 2004
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“For inclusion in this study, only patients who had been prescribed
a continuous drop regimen of loteprednol etabonate 0.2% at
least once per day for more than one year were selected.”
“For the purpose of this study, a significant IOP increase
was considered to be greater than 5mm Hg greater than the baseline
IOP measurement at the initial visit when the loteprednol etabonate
0.2% was prescribed. This is half the standard value of 10mm
Hg expected by the Food and Drug Administration for significant
IOP increases.”
“One hundred fifty-nine patients had been using loteprednol
etabonate 0.2% for more than one year. Eighty-four patients
had been using loteprednol etabinate 0.2% for at least two
years. Twenty-two patients had been using loteprednol etabinate
0.2% for at least three years. The number of drops per eye
per patient ranged from 120 to 3,741.”
“There were no recorded steroid-induced adverse effects (e.g.,
posterior subcapsular opacification) as a result of the long-term
topical loteprednol etabonate 0.2% therapy. There were no
incidences of steroid-induced IOP increases of more than 4mm
Hg.”
“Based on the findings of our study, this topical ophthalmic
steroid can be considered safe when used for the long-term
treatment of seasonal and perennial allergic conjunctivitis.
Routine slit lamp examination and monitoring of IOP in patients
using long-term topical steroids should still be performed.”
M & T Commentary:
While no steroid possesses absolute safety, this study showed
0.2% loteprednol to be safe for up to 3 years of continuous
use. While these findings are not surprising to practicing
clinicians, it is always reassuring when formal reviews confirm
our individual observations. We would very much like to
see a similar study on 0.5% loteprednol, since we use this
higher concentration much more than the 0.2%, especially
in our patients with presumed inflammation-related dry eyes.
This study clearly establishes the enhanced safety profile
of loteprednol. Whether using a once-daily eyedrop of loteprednol
would represent an overall greater quality of care for the
patient as compared to twice-daily usage of Restasis is not
known, and would require a long-term, prospective study to
elucidate this knowledge. |
