A Phase 3 interventional study of Ciprofloxacin-Fluocinolone Acetonide, 0.3%-0.025% Otic Solution and Ciprofloxacin 0.3% solution in Acute Otitis Externa, sponsored by Lee's Pharmaceutical Limited. Completed at 1 site in China. Open to participants aged 3 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Lee's Pharmaceutical Limited · Phase 3, Interventional, and Treatment
This is a phase Ⅲ, multicenter, randomized, evaluator-blinded, parallel-group, active-controlled study to assess the efficacy and safety of ciprofloxacin 0.3% plus fluocinolone acetonide 0.025% otic solution vs ciprofloxacin 0.3% otic solution in the treatment of acute otitis externa (AOE), and to assess the pharmacokinetic properties in 12 selected adult subjects. Eligible subjects will be randomized at 1:1 ration to either the treatment arm or control arm. All subject will receive 7 consecutive days of either ciprofloxacin 0.3% plus fluocinolone acetonide 0.025% otic solution or ciprofloxacin 0.3% otic solution alone. The main objectives are to assess the efficacy and safety of ciprofloxacin 0.3% plus fluocinolone acetonide 0.025% otic solution in the treatment of AOE, and to assess the plasma concentration of ciprofloxacin and fluocinolone acetonide after multiple doses of test drug in 12 adult subjects, and evaluate the pharmacokinetic parameters.
22 studies on the registry are indexed under Otitis Externa; 1 is open to participants now.
This study's enrollment of 600 is above the median of 100 across 20 interventional studies indexed under Otitis Externa.
Browse Otitis Externa studies →Lee's Pharmaceutical Limited is the lead sponsor of 74 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 13, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Warm the otic solution by holding the vial in the hands for 1 to 2 minutes. Twist off the vial cap. Tilt the subjects' head to one side to keep the affected ear up. Instill the content of 1 vial in the ear (0.25mL). Gently pull the outer ear lobe upward and outward to allow the solution to flow into the ear canal. Keep the subjects' head tilted sideways for approximately 5 minutes to allow the drug time to penetrate the ear. Use twice daily (every 12±1h , morning and evening) for 7 consecutive days.
Drug: Ciprofloxacin-Fluocinolone Acetonide, 0.3%-0.025% Otic Solution
Warm the otic solution by holding the vial in the hands for 1 to 2 minutes. Twist off the vial cap. Tilt the subjects' head to one side to keep the affected ear up. Instill 5 drops (0.25 mL) into the study ear. Gently pull the outer ear lobe upward and outward to allow the solution to flow into the ear canal. Keep the subjects' head tilted sideways for approximately 5 minutes to allow the drug time to penetrate the ear. Use twice daily (every 12±1h, morning and evening) for 7 consecutive days.
Drug: Ciprofloxacin 0.3% solution
0.25mL/vial, each vial contains 0.75mg of ciprofloxacin and 0.0625mg of fluocinolone acetonide.
0.4mL/vial, each vial contains 1.2mg ciprofloxacin
Also known as: CETRAXAL OTICO®
Clinical Cure
Clinical cure was reported as the number and percentage of participants with a score of 0 (absent) for each of 3 signs or symptoms: edema, otorrhea and ear tenderness. Each item was assessed using the investigator-rated 4-Point Scale for Clinical Efficacy Assessment, ranging from 0 to 3: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Higher scores indicated greater severity and a worse outcome. A score greater than 0 for any item was classified as clinical failure. For participants who achieved clinical cure at Visit 3 and completed the study early, the Visit 3 cure assessment was carried forward to End of Study.
Time frame: End of Study (Visit 4, Day 15+2)
Microbiological Cure
Microbiological response will be classified as Eradicated, Presumed Eradicated, Persistence, Presumed Persistence, Partial Eradication, Superinfection and Recurrence. Microbiological cure rate is defined as the percentage of patients who achieve the eradication and presumed eradication.
Time frame: Visit 3 (Day 8+2) and Visit 4 (Day 15+2)
Overall Therapeutic Cure
Overall therapeutic cure will only be assessed among subjects whose microbiological culture are positive at baseline. Overall therapeutic cure is defined as the percentage of patients who achieve both clinical cure and microbiological cure.
Time frame: Visit 3 (Day 8+2) and Visit 4 (Day 15+2)
Clinical Improvement
Clinical improvement was defined as an improvement of at least 1 grade from baseline (Visit 1) in any 1 of the 3 investigator-assessed clinical signs or symptoms (edema, otorrhea, or ear tenderness), without worsening in either of the other 2 assessments. The outcome was reported as the number and percentage of participants with clinical improvement at Visit 3 and Visit 4.
Time frame: Visit 3 (Day 8+2) and Visit 4 (Day 15+2)
Improvement in Each of Signs and Symptoms
Each sign or symptom (edema, otorrhea, and ear tenderness) was analyzed separately. For each assessment, improvement was defined as a decrease of at least 1 grade from baseline (Visit 1) and was reported as the number and percentage of participants with improvement at Visit 3 and Visit 4.
Time frame: Visit 3 (Day 8+2) and Visit 4 (Day 15+2)
Improvement in Granulation Tissue
Granulation tissue formation in the external auditory canal was assessed by the investigator using an otoscope or an ear, nose, and throat (ENT) video-endoscopy system and classified as absent (0) or present (1). Among participants with granulation tissue present at baseline (Visit 1), resolution was defined as granulation tissue absent at Visit 3 (Day 8+2) or Visit 4 (Day 15+2).
Time frame: Visit 3 (Day 8+2) and Visit 4 (Day 15+2)
Improvement of Ear Pain
Pain improvement is defined as ear pain improved ≥1 grade on 8 and 15 days after first dose, compared to the first day.
Time frame: Visit 3 (Day 8+2) and Visit 4 (Day 15+2)
Time to End of Ear Pain
Time to end of ear pain was calculated in days from the first dose to the last recorded resolution of ear pain (resolution date minus first-dose date plus 1). This endpoint was analyzed only among participants with ear pain at baseline. Participants whose ear pain had not resolved by the end of the study were censored according to the prespecified statistical analysis plan. If the last recorded resolution occurred after rescue medication, the participant was treated as not having pain resolution and was censored at the date of first rescue medication.
Time frame: From the first dose to the end of the study (Visit 4, Day 15+2)
A total of 39 study centers participated in this study. Overall, 701 subjects were screened, 101 subjects failed screening, and 600 subjects were randomized in a 1:1 ratio to the investigational group or the control group.
| Milestone | Ciprofloxacin 0.3% Plus Fluocinolone Acetonide 0.025% | Ciprofloxacin 0.3% |
|---|---|---|
| Started | 300 | 300 |
| Completed | 271 | 270 |
| Not completed | 29 | 30 |
Clinical cure was reported as the number and percentage of participants with a score of 0 (absent) for each of 3 signs or symptoms: edema, otorrhea and ear tenderness. Each item was assessed using the investigator-rated 4-Point Scale for Clinical Efficacy Assessment, ranging from 0 to 3: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Higher scores indicated greater severity and a worse outcome. A score greater than 0 for any item was classified as clinical failure. For participants who achieved clinical cure at Visit 3 and completed the study early, the Visit 3 cure assessment was carried forward to End of Study.
| Participants | Ciprofloxacin 0.3% Plus Fluocinolone Acetonide 0.025% | Ciprofloxacin 0.3% |
|---|---|---|
| Clinical Cure | 249 | 213 |
Microbiological response will be classified as Eradicated, Presumed Eradicated, Persistence, Presumed Persistence, Partial Eradication, Superinfection and Recurrence. Microbiological cure rate is defined as the percentage of patients who achieve the eradication and presumed eradication.
| Participants | Ciprofloxacin 0.3% Plus Fluocinolone Acetonide 0.025% | Ciprofloxacin 0.3% |
|---|---|---|
| Microbiological cure at Visit 3 (Day 8+2) | 196 | 186 |
| Microbiological cure at Visit 4 (Day 15+2) | 214 | 202 |
Overall therapeutic cure will only be assessed among subjects whose microbiological culture are positive at baseline. Overall therapeutic cure is defined as the percentage of patients who achieve both clinical cure and microbiological cure.
| Participants | Ciprofloxacin 0.3% Plus Fluocinolone Acetonide 0.025% | Ciprofloxacin 0.3% |
|---|---|---|
| Overall therapeutic cure at Visit 3 (Day 8+2) | 132 | 112 |
| Overall therapeutic cure at Visit 4 (Day 15+2) | 201 | 176 |
Clinical improvement was defined as an improvement of at least 1 grade from baseline (Visit 1) in any 1 of the 3 investigator-assessed clinical signs or symptoms (edema, otorrhea, or ear tenderness), without worsening in either of the other 2 assessments. The outcome was reported as the number and percentage of participants with clinical improvement at Visit 3 and Visit 4.
| Participants | Ciprofloxacin 0.3% Plus Fluocinolone Acetonide 0.025% | Ciprofloxacin 0.3% |
|---|---|---|
| Change in clinical improvement at Visit 3 (Day 8+2) | 271 | 263 |
| Change in clinical improvement at Visit 4 (Day 15+2) | 277 | 281 |
Each sign or symptom (edema, otorrhea, and ear tenderness) was analyzed separately. For each assessment, improvement was defined as a decrease of at least 1 grade from baseline (Visit 1) and was reported as the number and percentage of participants with improvement at Visit 3 and Visit 4.
| Participants | Ciprofloxacin 0.3% Plus Fluocinolone Acetonide 0.025% | Ciprofloxacin 0.3% |
|---|---|---|
| Edema Improvement at Visit 3 (Day 8+2) | 272 | 254 |
| Edema Improvement at Visit 4 (Day 15+2) | 277 | 278 |
| Otorrhea Improvement at Visit 3 (Day 8+2) | 235 | 206 |
| Otorrhea Improvement at Visit 4 (Day 15+2) | 272 | 254 |
| Tenderness Improvement at Visit 3 (Day 8+2) | 270 | 269 |
| Tenderness Improvement at Visit 4 (Day 15+2) | 278 | 286 |
Granulation tissue formation in the external auditory canal was assessed by the investigator using an otoscope or an ear, nose, and throat (ENT) video-endoscopy system and classified as absent (0) or present (1). Among participants with granulation tissue present at baseline (Visit 1), resolution was defined as granulation tissue absent at Visit 3 (Day 8+2) or Visit 4 (Day 15+2).
| Participants | Ciprofloxacin 0.3% Plus Fluocinolone Acetonide 0.025% | Ciprofloxacin 0.3% |
|---|---|---|
| Granulation Tissue Resolution at Visit 3 (Day 8+2) | 3 | 1 |
| Granulation Tissue Resolution at Visit 4 (Day 15+2) | 3 | 2 |
Pain improvement is defined as ear pain improved ≥1 grade on 8 and 15 days after first dose, compared to the first day.
| Participants | Ciprofloxacin 0.3% Plus Fluocinolone Acetonide 0.025% | Ciprofloxacin 0.3% |
|---|---|---|
| Ear pain improvement (≥1 grade) at Visit 3 (Day 8+2) | 253 | 252 |
| Ear pain improvement (≥1 grade) at Visit 4 (Day 15+2) | 263 | 268 |
Time to end of ear pain was calculated in days from the first dose to the last recorded resolution of ear pain (resolution date minus first-dose date plus 1). This endpoint was analyzed only among participants with ear pain at baseline. Participants whose ear pain had not resolved by the end of the study were censored according to the prespecified statistical analysis plan. If the last recorded resolution occurred after rescue medication, the participant was treated as not having pain resolution and was censored at the date of first rescue medication.
| Days | Ciprofloxacin 0.3% Plus Fluocinolone Acetonide 0.025% | Ciprofloxacin 0.3% |
|---|---|---|
| Time to End of Ear Pain | 5 (5 to 6) | 5 (5 to 6) |
Collected over Adverse events were collected from the first administration of study drug through the end of study (Visit 4, Day 15+2), with additional follow-up for selected subjects up to Day 22+7.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ciprofloxacin 0.3% Plus Fluocinolone Acetonide 0.025% | 0/296 (0%) | 2/296 (0.7%) | 34/296 (11.5%) |
| Ciprofloxacin 0.3% | 0/296 (0%) | 0/296 (0%) | 41/296 (13.9%) |
| Event | Ciprofloxacin 0.3% Plus Fluocinolone Acetonide 0.025% | Ciprofloxacin 0.3% |
|---|---|---|
| TuberculosisInfections and infestations | 1/296 | 0/296 |
| Knee deformityMusculoskeletal and connective tissue disorders | 1/296 | 0/296 |
| Event | Ciprofloxacin 0.3% Plus Fluocinolone Acetonide 0.025% | Ciprofloxacin 0.3% |
|---|---|---|
| Fungal otitis externaInfections and infestations | 24/296 | 26/296 |
| Pruritus earGeneral disorders | 10/296 | 15/296 |
Baseline characteristics were summarized for the Clinical Intent-to-Treat (CITT) Population, defined as all randomized participants who received at least 1 dose of study treatment. Of 600 randomized participants, 8 did not receive study treatment (5 in the combination arm and 3 in the ciprofloxacin arm) and were excluded. Therefore, 295 participants in the combination arm and 297 participants in the ciprofloxacin arm (592 total) were included in the baseline analysis.
| Age, Customized(Participants) | Ciprofloxacin 0.3% Plus Fluocinolone Acetonide 0.025% | Ciprofloxacin 0.3% | Total |
|---|---|---|---|
| Age, Categorical — <12 years | 47 | 43 | 90 |
| Age, Categorical — 12-64 years | 239 | 248 | 487 |
| Age, Categorical — >64 years | 9 | 6 | 15 |
| Sex: Female, Male(Participants) | Ciprofloxacin 0.3% Plus Fluocinolone Acetonide 0.025% | Ciprofloxacin 0.3% | Total |
|---|---|---|---|
| Female | 147 | 141 | 288 |
| Male | 148 | 156 | 304 |
| Race/Ethnicity, Customized(Participants) | Ciprofloxacin 0.3% Plus Fluocinolone Acetonide 0.025% | Ciprofloxacin 0.3% | Total |
|---|---|---|---|
| Race/Ethnicity, Customized — Han Chinese | 282 | 278 | 560 |
| Race/Ethnicity, Customized — Other | 13 | 19 | 32 |
| AOE Severity(Participants) | Ciprofloxacin 0.3% Plus Fluocinolone Acetonide 0.025% | Ciprofloxacin 0.3% | Total |
|---|---|---|---|
| Grade II (Moderate) | 262 | 258 | 520 |
| Grade III (Severe) | 33 | 39 | 72 |
| Swelling(Participants) | Ciprofloxacin 0.3% Plus Fluocinolone Acetonide 0.025% | Ciprofloxacin 0.3% | Total |
|---|---|---|---|
| Grade 2 (Moderate) | 232 | 235 | 467 |
| Grade 3 (Severe) | 63 | 62 | 125 |
| Otorrhea(Participants) | Ciprofloxacin 0.3% Plus Fluocinolone Acetonide 0.025% | Ciprofloxacin 0.3% | Total |
|---|---|---|---|
| Grade 1 (Mild) | 130 | 133 | 263 |
| Grade 2 (Moderate) | 131 | 133 | 264 |
| Grade 3 (Severe) | 34 | 31 | 65 |
| Tenderness(Participants) | Ciprofloxacin 0.3% Plus Fluocinolone Acetonide 0.025% | Ciprofloxacin 0.3% | Total |
|---|---|---|---|
| Grade 2 (Moderate) | 264 | 269 | 533 |
| Grade 3 (Severe) | 31 | 28 | 59 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2021 to primary completion in Oct 2021, 9 months.
Results were first posted in Oct 2026, 4 years 11 months after primary completion.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 13, 2026: start Nov 2020 → Jan 2021, primary completion Dec 2021 → Oct 2021 and completion Jul 2022 → Oct 2021.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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