Comparison of the safety and efficacy of loteprednol 0.5%/tobramycin 0.3% with
dexamethasone 0.1%/tobramycin 0.3% in the treatment of
blepharokeratoconjunctivitis.
Author(s): White EM, Macy JI, Bateman KM, Comstock TL.
Affiliation(s): Complete Family Vision Care, San Diego, CA, USA.
Publication date & source: 2008, Curr Med Res Opin. , 24(1):287-96
OBJECTIVE: This study compared the safety and efficacy of loteprednol etabonate
0.5%/tobramycin 0.3% (LE/T; Zylet) with dexamethasone 0.1%/tobramycin 0.3% (DM/T;
Tobradex) in the treatment of ocular inflammation associated with
blepharokeratoconjunctivitis. Research design and methods: This was a
multicenter, randomized, investigator-masked, parallel-group study. Subjects with
clinically diagnosed blepharokeratocon-junctivitis in at least one eye were
randomized to LE/T (n = 138) or DM/T (n = 138) administered four times per day,
for 14 days. The primary efficacy endpoint was the change from baseline to Day 15
(+/- 1 day) in the signs and symptoms composite score using a non-inferiority
metric to compare LE/T to DM/T. Safety endpoints included visual acuity (VA),
biomicroscopy, intraocular pressure (IOP) assessments, and adverse events.
RESULTS: At Day 15, the mean (SD) change from baseline in the signs and symptoms
composite score was -15.2 (7.3) for LE/T-treated subjects and -15.6 (7.7) for
DM/T-treated subjects. The upper bound of the 90% confidence interval for the
difference in change from baseline was less than the non-inferiority margin not
only at Day 15 but also at Day 7 and Day 3 for both the intent-to-treat and per
protocol populations. Subjects treated with DM/T experienced a significant
increase in IOP versus those treated with LE/T at Day 7, Day 15, and overall
(mean [SD] of 0.6 [2.3] vs, -0.1 [2.2], p = 0.03, 1.0 [3.0] vs. -0.1 [2.4], p =
0.01, and 2.3 [2.3] vs. 1.6 [1.7], p = 0.02, respectively).
CONCLUSIONS: LE/T satisfied the condition of non-inferiority to DM/T in
decreasing the signs and symptoms of ocular inflammation associated with
blepharokeratoconjunctivitis. Subjects treated with DM/T experienced more of an
increase in IOP. Limitation: Although the single-masked design of this study
could be considered a limitation, care was taken to ensure that the investigator
was masked.
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