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Ciprofloxacin plus fluocinolone otic solution studied in 600 adults with otitis externaTrial Shows Ciprofloxacin and Fluocinolone for Otitis Externa Treatment
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Key Takeaway
Interpret with caution: no efficacy or safety results are available for this otic combination in otitis externa.
This was a randomized, evaluator-blinded, parallel-group, active-controlled phase 3 study conducted across multiple centers. It enrolled 600 adults with otitis externa. Participants received either ciprofloxacin 0.3% plus fluocinolone acetonide 0.025% otic solution or ciprofloxacin 0.3% otic solution alone. Treatment duration was 7 consecutive days.
The primary outcome was clinical cure. Secondary outcomes included safety, plasma concentrations of ciprofloxacin and fluocinolone acetonide, and pharmacokinetic parameters. The main results for clinical cure were not reported, including effect size, absolute numbers, and p-value or confidence interval. Direction of effect was also not reported.
Safety data were not reported. Adverse events, serious adverse events, discontinuations, and tolerability were all listed as not reported. No limitations were provided in the source record.
Funding was reported from Lee's Pharmaceutical Limited. Practice relevance was not reported. Because results are not yet posted, no conclusions can be drawn about the comparative efficacy or safety of the combination otic solution versus ciprofloxacin alone in this population.
How this fits prior evidence
This trial addresses a gap in prior coverage, which has not reported on topical otic antibiotic and corticosteroid combinations for otitis externa. Prior items covered in vitro antimicrobial activity of Euphorbia hirta against ESKAPE pathogens, a fluocinolone acetonide implant for diabetic macular edema, Salmonella prevalence in Ethiopia, Gram-negative contamination of dental unit waterlines, and high fluoroquinolone resistance in E. coli causing UTIs. The current study evaluates a fluoroquinolone plus corticosteroid otic solution in adults with otitis externa, but no outcome data are available to confirm or contrast with those findings.
A phase 3 clinical trial was conducted to study the effectiveness of a specific ear drop treatment. The study involved 600 adults suffering from otitis externa, which is an infection of the outer ear. The researchers compared a combination of ciprofloxacin 0.3% and fluocinolone acetonide 0.025% against a solution containing only ciprofloxacin 0.3%.
The study was designed to measure the clinical cure rate over a seven-day treatment period. It also looked at safety data and how the medications moved through the body. These measurements help doctors understand how the drugs behave in the body and if they are safe for patients.
Because the final results for the primary outcomes have not been reported yet, it is not yet clear how much better the combination treatment performed compared to the single ingredient. This study is still in the process of providing data for medical use. Patients should continue to follow their current treatment plans and speak with a doctor for medical advice.
What this means for you:
A large trial is testing a combination ear drop for ear infections, but final results are not yet available.
Common questions
What is being tested for ear infections?
The study is testing a combination of ciprofloxacin 0.3% and fluocinolone acetonide 0.025% as an otic solution. This is being compared to a solution containing only ciprofloxacin 0.3% to see how it treats otitis externa in adults.
How many people were involved in this study?
The study included a large group of 600 adults. This multicenter trial was designed to evaluate the treatment over a period of 7 consecutive days.
Are the results of this study available yet?
The results for the primary outcome of clinical cure have not been reported yet. Because the data is not yet available, it is not yet known if the combination treatment is more effective than the single ingredient.
Status: COMPLETED | Phase: PHASE3
Condition(s): Acute Otitis Externa
Intervention(s): Ciprofloxacin-Fluocinolone Acetonide, 0.3%-0.025% Otic Solution (DRUG), Ciprofloxacin 0.3% solution (DRUG)
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.
Primary Outcome(s): Clinical Cure
Enrollment: 600 (ACTUAL)
Lead Sponsor: Lee's Pharmaceutical Limited
Start: 2021-01-04 | Primary Completion: 2021-10-17
Results posted: 2026-10-13
