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.
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.


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.


CONCLUSIONS
Although the single-masked design of this study could be considered a limitation, care was taken to ensure that the investigator was masked.
White
Eric M
EM
Complete Family Vision Care, San Diego, CA, USA.
Macy
Jonathan I
JI
Bateman
Kirk M
KM
Comstock
Timothy L
TL
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000730:Androstadienes / Q000008:administration & dosage* / Q000009:adverse effects; D018926:Anti-Allergic Agents / Q000008:administration & dosage / Q000009:adverse effects; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000009:adverse effects; D001762:Blepharitis / Q000150:complications / Q000188:drug therapy*; D003907:Dexamethasone / Q000008:administration & dosage* / Q000009:adverse effects; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects; D007637:Keratoconjunctivitis / Q000150:complications / Q000188:drug therapy*; D000069559:Loteprednol Etabonate; D008297:Male; D008875:Middle Aged; D014031:Tobramycin / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D014792:Visual Acuity / Q000187:drug effects
D000730:Androstadienes; D018926:Anti-Allergic Agents; D000900:Anti-Bacterial Agents; D000893:Anti-Inflammatory Agents; D004338:Drug Combinations; D003907:Dexamethasone; D014031:Tobramycin; D000069559:Loteprednol Etabonate