Lee's Pharmaceutical posts Phase 3 results for ciprofloxacin-fluocinolone ear drops

Lee's Pharmaceutical Limited has posted results for a Phase 3 trial of ciprofloxacin 0.3% plus fluocinolone acetonide 0.025% otic solution in acute otitis externa (AOE). The trial registry record for NCT04636957 lists the results as first posted on October 13, 2026. The record lists clinical cure at the end of the study for 249 of 295 participants on the combination and 213 of 297 on ciprofloxacin 0.3% alone.

What the record says about the design

The record calls the study a Phase III, multicenter, randomized, evaluator-blinded, parallel-group, active-controlled clinical trial. Participants were randomized 1:1 to the combination or to ciprofloxacin 0.3% otic solution alone. Both arms used the drops twice daily for 7 consecutive days.

The record says 701 participants were screened, 101 did not pass screening and 600 were randomized, 300 to each arm. A total of 39 study centers took part. The record lists the start as January 4, 2021 and primary completion as October 17, 2021.

Adults and children aged 3 years or older could join. They needed a diagnosis of diffuse AOE within 21 days before screening, at Grade II or III, with at least Grade 2 edema, at least Grade 2 ear tenderness and at least Grade 1 otorrhea at the same time. Of the 600 randomized, 271 completed in the combination arm and 270 in the ciprofloxacin arm.

The record's baseline table covers the 592 participants who received at least one dose: 295 in the combination arm and 297 in the ciprofloxacin arm. It lists 520 with Grade II disease and 72 with Grade III. It lists 560 as Han Chinese.

The primary outcome

The record lists one primary outcome, clinical cure at the end of the study (Visit 4, Day 15+2). It defines cure as a score of 0 (absent) for each of 3 signs or symptoms: edema, otorrhea and ear tenderness, each rated by the investigator from 0 to 3. A score greater than 0 for any item counts as clinical failure.

For the 295 participants on the combination, the record lists 249 as cured. For the 297 on ciprofloxacin alone, it lists 213. The record posts no statistical comparison for this outcome.

Secondary outcomes in the record

The record lists microbiological cure for the 244 participants on the combination and 248 on ciprofloxacin who had a baseline pathogen. At Visit 3 (Day 8+2) it lists 196 and 186. At Visit 4 (Day 15+2) it lists 214 and 202.

The record lists therapeutic cure, for the same participants, as 132 against 112 at Visit 3 and 201 against 176 at Visit 4.

For ear pain, the record covers 279 participants on the combination and 286 on ciprofloxacin who had pain at baseline. Improvement of at least 1 grade was listed for 253 and 252 at Visit 3, and 263 and 268 at Visit 4. The median time to the end of ear pain was 5 days in both arms, with a 95% confidence interval of 5 to 6.

Safety counts in the record

The safety set had 296 participants in each arm. The record lists no deaths. It lists serious adverse events in 2 participants on the combination and 0 on ciprofloxacin alone: tuberculosis in 1 participant and knee deformity in 1 participant, both in the combination arm.

Other adverse events above the 5 reporting threshold were listed in 34 participants on the combination and 41 on ciprofloxacin. Fungal otitis externa was listed in 24 and 26. Pruritus ear was listed in 10 and 15.

Lee's Pharmaceutical posted these figures as summary data in the registry. The record is the sponsor's report, and this story reports its numbers as posted.