Loteprednol Etabonate Ophthalmic Gel 0.5% Following Cataract Surgery: Integrated Analysis of Two Clinical Studies
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ORIGINAL RESEARCH
Loteprednol Etabonate Ophthalmic Gel 0.5% Following Cataract Surgery: Integrated Analysis of Two Clinical Studies Rajesh K. Rajpal • Raymond Fong • Timothy L. Comstock
To view enhanced content go to www.advancesintherapy.com Received: August 8, 2013 / Published online: October 18, 2013 Ó Springer Healthcare 2013
ABSTRACT
drops of LE gel 0.5% or vehicle 4 times per day
Introduction: We aimed to evaluate the safety
instilled in the study eye for 14 days. Primary outcome measures included the proportion of
and efficacy of loteprednol etabonate (LE) gel
patients with complete resolution of ACC and
0.5% compared with vehicle in the treatment of postoperative inflammation and pain following
grade 0 (no) pain on postoperative Day 8. Safety endpoints included adverse events (AEs),
cataract surgery, using the integrated analysis of data from two identical, prospective,
changes from baseline in intraocular pressure (IOP) and visual acuity (VA), biomicroscopy,
multicenter,
double-masked,
and funduscopy findings. Gel comfort was
parallel-group, vehicle-controlled trials. Methods: Patients with anterior chamber cell
graded by patients according to drop sensation. Results: The intent-to-treat population included
(ACC) inflammation C grade 2 (6–15 cells) 1 day post-surgery were randomized to receive 1 or 2
813 patients (409 LE gel 0.5% and 404 vehicle). At postoperative Day 8, 30.8% and 15.1% of patients
randomized,
randomized Clinicaltrials.gov NCT 01010633 and NCT 01060072. R. K. Rajpal (&) See Clearly Vision Group, 8138 Watson Street, McLean, VA 22102, USA e-mail: [email protected]
to
LE
gel
0.5%
or
vehicle,
respectively, had complete resolution of ACC, while 74.3% and 43.8% of patients, respectively, had grade 0 pain (P\0.001 for both). Tolerability assessments for ocular itching, photophobia, and tearing favored LE gel 0.5% compared with
R. Fong Eye Care, Flushing, NY, USA
vehicle at different time points beginning at Day 3. Two patients in the LE gel 0.5% group and 1
T. L. Comstock Bausch and Lomb Inc., Rochester, NY, USA
patient in the vehicle group exhibited a transient treatment-emergent increase in IOP C 10 mmHg. Treatment-related AEs were generally mild to
Enhanced content for Advances in Therapy articles is available on the journal web site: www.advancesintherapy.com
moderate and occurred less frequently with LE gel 0.5% than with vehicle. Reports of treatmentrelated blurred vision were rare (n = 2, vehicle).
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Adv Ther (2013) 30:907–923
908
Conclusion: LE gel 0.5% was efficacious and
Three topical corticosteroids are currently
well tolerated in the treatment of postoperative pain and inflammation following ocular
marketed for the treatment of postoperative
surgery, with minimal risk of IOP elevation.
ocular inflammation in the USA: loteprednol etabonate (LE), rimexolone, and difluprednate
Keywords: Anterior chamber cell; Anterior
[11–13]. Structurally, LE is unique from other corticosteroids in the replacement of the carbon
chamber cell inflammatio
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