TABLE 2.

Clinical Efficacy

Efficacy VariableCiprofloxacin/DexamethasoneOfloxacinP Value
Primary efficacyN = 80 (MPP)N = 170 (MPP)
 Clinical cure at TOC162 (90.0%)133 (78.2%).0025
 Micro eradication at TOC165 (92.0%)139 (81.8%).0061
 Treatment failures8 (4.4%)24 (14.1%).0017
 Secondary efficacyN = 207 (MITT)N = 216 (MITT)
 Median time to cessation of otorrhea4.0 d6.0 d.0209§
 Physicians’ assessment of response
  Day 3
   Cured64 (30.9%)38 (17.6%)<.0001
   Improved130 (62.8%)134 (62.0%)
   Unchanged9 (4.4%)35 (16.2%)
   Worsened4 (1.9%)9 (4.2%)
  Day 11*
   Cured174 (84.1%)136 (63.0%)<.0001
   Improved25 (12.1%)58 (26.9%)
   Unchanged4 (1.9%)12 (5.6%)
   Worsened4 (1.9%)10 (4.6%)
  Day 18
   Cured174 (84.1%)153 (70.8%).0023
   Improved20 (9.7%)38 (17.6%)
   Unchanged6 (2.9%)12 (5.7%)
   Worsened7 (3.4%)13 (6.0%)
 Absence of otorrhea
  Day 367 (32.2%)40 (18.5%).0012
  Day 11176 (84.6%)137 (63.4%)<.0001
  Day 18*176 (85.0%)153 (70.8%).0004
 Reduction of otorrhea volume
  Day 3*66 (31.9%)39 (18.1%)<.0001
  Day 11*175 (84.5%)136 (63.0%)<.0001
  Day 18175 (85.0%)153 (70.8%).0003
  • MPP indicates modified per protocol; MITT, modified ITT; CI, confidence interval; LS, least square.

  • * Data missing in 1 patient who received ciprofloxacin/dexamethasone.

  • Data missing in 2 patients who received ciprofloxacin/dexamethasone.

  • χ2 test of independence (Fisher’s exact test when n < 5).

  • § Log-rank test (Kaplan-Meier survival analysis).

  • Treatment difference from LS means (mixed model analysis of variance).