Efficacy and safety of topical ciprofloxacin/dexamethasone versus neomycin/polymyxin B/hydrocortisone for otitis externa.
OBJECTIVE
To compare the efficacy and safety of ciprofloxacin 0.3%/dexamethasone 0.1% (CIP/DEX) otic suspension with that of neomycin 0.35%/polymyxin B 10,000 IU/mL/hydrocortisone 1.0% (N/P/H) otic suspension in patients with acute otitis externa (AOE).


METHODS
Randomized, observer-masked, parallel-group, multicenter study. Patients were randomized to 7 days treatment with either CIP/DEX 3-4 drops twice daily or N/P/H 3-4 drops three times daily.


METHODS
Patients of either sex and older than 1 year, with a clinical diagnosis of mild, moderate, or severe AOE and intact tympanic membranes were recruited to participate.


METHODS
Signs and symptoms of AOE, including ear inflammation, tenderness, edema and discharge (assessed on Days 3, 8 [End-of-Therapy] and 18 [Test-of-Cure]); microbiologic eradication (presumed or documented); and frequency of adverse events.


RESULTS
Patients enrolled numbered 468. In culture-positive patients who met the inclusion criteria (N = 396), clinical cure rates at Day 18 were significantly higher with CIP/DEX than with N/P/H (90.9% vs. 83.9%; p = 0.0375), as were microbiologic eradication rates (94.7% vs. 86.0%; p = 0.0057). In addition, the clinical response was significantly better with CIP/DEX than with N/P/H at Days 3 and 18 (p = 0.0279 and p = 0.0321, respectively), as was the reduction in ear inflammation at Day 18 (p = 0.0268). Both preparations were well tolerated in pediatric and adult patients.


CONCLUSIONS
7 days treatment with CIP/DEX otic suspension administered twice daily is clinically and microbiologically superior to N/P/H otic suspension administered 3 times daily in the treatment of mild to severe AOE, and is equally well tolerated.
Department of Otolaryngology, University of Texas Southwestern Medical Center, Dallas, Texas 75390-9035, USA. peter.roland@utsouthwestern.edu
Peter S
PS
Roland
Francis D
FD
Pien
Craig C
CC
Schultz
Dan C
DC
Henry
Peter J
PJ
Conroy
G Michael
GM
Wall
Rekha
R
Garadi
Sheryl J
SJ
Dupre
Susan L
SL
Potts
L Gail
LG
Hogg
David W
DW
Stroman
D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D002939:Ciprofloxacin / Q000008:administration & dosage*; D004338:Drug Combinations; D005260:Female; D005601:Framycetin / Q000008:administration & dosage*; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D010032:Otitis Externa / Q000188:drug therapy*; D019999:Pharmaceutical Solutions / Q000008:administration & dosage; D011112:Polymyxin B / Q000008:administration & dosage*; D016037:Single-Blind Method; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D000893:Anti-Inflammatory Agents; D004338:Drug Combinations; D019999:Pharmaceutical Solutions; D005601:Framycetin; D002939:Ciprofloxacin; D011112:Polymyxin B