Trial · NCT04636957
Efficacy and Safety of Ciprofloxacin Plus Fluocinolone Acetonide Otic Solution in the Treatment of Acute Otitis Externa
NCT04636957, Phase 3, Completed, Lee's Pharmaceutical Limited
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Ciprofloxacin Plus Fluocinolone Acetonide Otic Solution in the Treatment of Acute Otitis Externa. Trials, record NCT04636957. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04636957
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Ciprofloxacin Plus Fluocinolone Acetonide Otic Solution in the Treatment of Acute Otitis Externa
- NCT number
- NCT04636957
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 600 participants, actual
- Lead sponsor
- Lee's Pharmaceutical Limited
- Conditions
- Acute Otitis Externa
- Interventions
- Ciprofloxacin-Fluocinolone Acetonide, 0.3%-0.025% Otic Solution, Ciprofloxacin 0.3% solution
- First posted
- 2020-11-19
- Last updated
- 2026-10-13
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Cure | End of Study (Visit 4, Day 15+2) | 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. |
| Secondary | Microbiological Cure | Visit 3 (Day 8+2) and Visit 4 (Day 15+2) | 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. |
| Secondary | Overall Therapeutic Cure | Visit 3 (Day 8+2) and Visit 4 (Day 15+2) | 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. |
| Secondary | Clinical Improvement | Visit 3 (Day 8+2) and Visit 4 (Day 15+2) | 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. |
| Secondary | Improvement in Each of Signs and Symptoms | Visit 3 (Day 8+2) and Visit 4 (Day 15+2) | 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. |
| Secondary | Improvement in Granulation Tissue | Visit 3 (Day 8+2) and Visit 4 (Day 15+2) | 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). |
| Secondary | Improvement of Ear Pain | Visit 3 (Day 8+2) and Visit 4 (Day 15+2) | Pain improvement is defined as ear pain improved ≥1 grade on 8 and 15 days after first dose, compared to the first day. |
| Secondary | Time to End of Ear Pain | From the first dose to the end of the study (Visit 4, Day 15+2) | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04636957
GET https://conductscience.org/api/trials/v1/NCT04636957/registered