Tolerability of loteprednol/tobramycin versus dexamethasone/tobramycin in healthy volunteers: results of a 4-week, randomized, double-masked, parallel-group study.
OBJECTIVE
To compare the ocular comfort and tolerability of loteprednol etabonate 0.5%/tobramycin 0.3% (LE/T; Zylet) with dexamethasone 0.1%/tobramycin 0.3% (DM/T; TobraDex) in healthy volunteers.


METHODS
In this multicenter, randomized, double-masked, parallel-group study, healthy volunteers (n = 306) were randomized to receive LE/T or DM/T four times per day for 28 days. Subjects recorded subjective ratings for seven comfort/tolerability parameters using an electronic patient diary (EPD). The primary endpoint was the difference at week 4 from the ratings of an artificial tear at baseline in comfort/tolerability parameters between treatment groups, using a noninferiority paradigm.


BACKGROUND
ClinicalTrials. gov, NCT 00532961.


RESULTS
The 97.5% confidence intervals for the lower bound were within -10 for all of the seven comfort/ tolerability parameters evaluated (pain, stinging/burning, irritation, itchiness, foreign-body sensation, dryness, and light sensitivity). Secondary analysis revealed small but significant within-treatment differences in pain favoring LE/T over tears and in light sensitivity favoring tears over DM/T (p < 0.01). Small between-treatment differences in the changes from baseline tear ratings to individual study visits favored LE/T for pain, stinging/burning, irritation, itchiness, foreign-body sensation, and light sensitivity at visit 4 (p < or = 0.04); for pain, stinging/burning, and foreignbody sensation at visit 5 (p < or = 0.03), and for dryness and light sensitivity at visit 6 (p < or = 0.05).


CONCLUSIONS
LE/T satisfied all conditions of noninferiority to DM/T in comfort and tolerability. Subjects receiving LE/T were more likely to report better ocular comfort/tolerability ratings relative to baseline artificial tears than subjects receiving DM/T.


CONCLUSIONS
The study population consisted of healthy volunteers.
Bartlett
Jimmy D
JD
Department of Optometry, School of Optometry, University of Alabama at Birmingham, Birmingham, AL 35294-0010, USA. eyedrug@uab.edu
Holland
Edward J
EJ
Usner
Dale W
DW
Paterno
Michael R
MR
Comstock
Timothy L
TL
D000293:Adolescent; D000328:Adult; D000368:Aged; D000730:Androstadienes / Q000008:administration & dosage*; D003907:Dexamethasone / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D000069559:Loteprednol Etabonate; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D014031:Tobramycin / Q000008:administration & dosage*
D000730:Androstadienes; D003907:Dexamethasone; D014031:Tobramycin; D000069559:Loteprednol Etabonate