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Last Updated: March 17, 2025

CLINICAL TRIALS PROFILE FOR CIPROFLOXACIN HYDROCHLORIDE; FLUOCINOLONE ACETONIDE


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All Clinical Trials for ciprofloxacin hydrochloride; fluocinolone acetonide

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT04636957 ↗ A Phase III Study of Ciprofloxacin Plus Fluocinolone in Acute Otitis Externa (AOE) Not yet recruiting Lee's Pharmaceutical Limited Phase 3 2020-11-01 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 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 PK parameters.
>Trial ID>Title>Status>Phase>Start Date>Summary
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Clinical Trial Conditions for ciprofloxacin hydrochloride; fluocinolone acetonide

Condition Name

10-0.100.10.20.30.40.50.60.70.80.911.1Acute Otitis Externa[disabled in preview]
Condition Name for ciprofloxacin hydrochloride; fluocinolone acetonide
Intervention Trials
Acute Otitis Externa 1
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Condition MeSH

110-0.100.10.20.30.40.50.60.70.80.911.1Otitis ExternaOtitis[disabled in preview]
Condition MeSH for ciprofloxacin hydrochloride; fluocinolone acetonide
Intervention Trials
Otitis Externa 1
Otitis 1
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Clinical Trial Locations for ciprofloxacin hydrochloride; fluocinolone acetonide

Trials by Country

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Trials by Country for ciprofloxacin hydrochloride; fluocinolone acetonide
Location Trials
China 1
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Clinical Trial Progress for ciprofloxacin hydrochloride; fluocinolone acetonide

Clinical Trial Phase

100.0%0-0.100.10.20.30.40.50.60.70.80.911.1Phase 3[disabled in preview]
Clinical Trial Phase for ciprofloxacin hydrochloride; fluocinolone acetonide
Clinical Trial Phase Trials
Phase 3 1
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Clinical Trial Status

100.0%0-0.100.10.20.30.40.50.60.70.80.911.1Not yet recruiting[disabled in preview]
Clinical Trial Status for ciprofloxacin hydrochloride; fluocinolone acetonide
Clinical Trial Phase Trials
Not yet recruiting 1
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Clinical Trial Sponsors for ciprofloxacin hydrochloride; fluocinolone acetonide

Sponsor Name

trials000001111111Lee's Pharmaceutical Limited[disabled in preview]
Sponsor Name for ciprofloxacin hydrochloride; fluocinolone acetonide
Sponsor Trials
Lee's Pharmaceutical Limited 1
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Sponsor Type

100.0%0-0.100.10.20.30.40.50.60.70.80.911.1Industry[disabled in preview]
Sponsor Type for ciprofloxacin hydrochloride; fluocinolone acetonide
Sponsor Trials
Industry 1
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Ciprofloxacin Hydrochloride and Fluocinolone Acetonide: Clinical Trials, Market Analysis, and Projections

Introduction

Ciprofloxacin hydrochloride and fluocinolone acetonide are two active ingredients often combined in otic solutions to treat various ear infections. This article provides an update on the clinical trials, market analysis, and future projections for this combination.

Clinical Trials Overview

Acute Otitis Media with Tympanostomy Tubes (AOMT)

Clinical trials for the combination of ciprofloxacin 0.3% and fluocinolone acetonide 0.025% otic solution have been conducted to evaluate its efficacy and safety in treating AOMT in pediatric patients. Two phase 3, multicenter, randomized, double-blind clinical trials (CIFLOTIII/10IA02 and CIFLOTIII/10IA04) were initiated in July 2011, enrolling 662 subjects. These studies demonstrated the superiority of the combination over individual components in terms of time to cessation of otorrhea and sustained microbiological cure[2][3].

Acute Otitis Externa (AOE)

A phase 3 randomized, double-blind, active-controlled clinical trial conducted between August 2017 and September 2018 evaluated the efficacy and safety of ciprofloxacin 0.3% plus fluocinolone acetonide 0.025% otic solution in treating AOE. The study involved 493 patients and showed that the combination was efficacious and safe, although it did not demonstrate superiority over ciprofloxacin or fluocinolone alone in the primary endpoint of therapeutic cure. However, it did show statistical superiority in sustained microbiological response and faster resolution of otalgia[3].

Efficacy and Safety Findings

Therapeutic Outcomes

The combination of ciprofloxacin and fluocinolone acetonide has been shown to be effective in treating both AOMT and AOE. In AOMT, it demonstrated superiority over individual components in terms of time to cessation of otorrhea and sustained microbiological cure. For AOE, the combination showed a faster resolution of ear pain and superior sustained microbiological response compared to ciprofloxacin or fluocinolone alone[2][3].

Safety Profile

The safety profile of the combination has been favorable. Clinical trials reported low rates of adverse events, with most being mild or moderate. Common adverse events included pyrexia, otitis media, rhinorrhea, cough, upper respiratory tract infection, and otorrhea. No treatment-related serious adverse events were reported in the trials[2][5].

Market Analysis

Current Market Presence

The combination of ciprofloxacin 0.3% and fluocinolone acetonide 0.025% otic solution is marketed under various brand names, such as Cetraxal Plus and OTIXAL. It has received marketing approval in several countries, including Spain, where it was first approved in 2002. In the US, it is approved for the treatment of AOMT in pediatric patients aged 6 months and older[2][3].

Market Competition

The otic solution market is competitive, with other formulations containing ciprofloxacin or fluocinolone acetonide also available. Products like Ciprodex, which combines ciprofloxacin with dexamethasone, are approved for AOE and AOMT. However, the combination of ciprofloxacin and fluocinolone acetonide has a unique position due to its demonstrated efficacy and safety profile[2][5].

Market Projections

Growth Potential

The market for otic solutions is expected to grow due to increasing incidence of ear infections and the need for effective treatments. The combination of ciprofloxacin and fluocinolone acetonide is likely to benefit from this trend, given its proven efficacy and safety. Expansion into new markets and increasing awareness among healthcare providers are expected to drive growth.

Regulatory Environment

Regulatory approvals and recommendations play a crucial role in market projections. The FDA's approval of ciprofloxacin 0.3% plus fluocinolone acetonide 0.025% otic solution for AOMT and AOE has been a significant factor in its market presence. Continued regulatory support and potential approvals in additional indications could further boost market growth[2][3].

Key Takeaways

  • Efficacy: The combination of ciprofloxacin 0.3% and fluocinolone acetonide 0.025% otic solution has demonstrated efficacy in treating AOMT and AOE, with superior outcomes in sustained microbiological response and faster resolution of otalgia.
  • Safety: The safety profile is favorable, with low rates of adverse events, most of which are mild or moderate.
  • Market Presence: The product is approved and marketed in several countries, with a competitive position in the otic solution market.
  • Growth Potential: The market is expected to grow due to increasing incidence of ear infections and the need for effective treatments.

FAQs

What are the primary indications for ciprofloxacin 0.3% plus fluocinolone acetonide 0.025% otic solution?

The primary indications are acute otitis media with tympanostomy tubes (AOMT) and acute otitis externa (AOE).

What are the key findings from clinical trials for this combination?

Clinical trials have shown that the combination is efficacious and safe, with superior outcomes in sustained microbiological response and faster resolution of otalgia compared to individual components.

What is the safety profile of this combination?

The safety profile is favorable, with low rates of adverse events, most of which are mild or moderate.

Which regulatory bodies have approved this combination?

The FDA has approved this combination for AOMT and AOE, and it has also received approvals in several other countries.

What is the market competition like for this product?

The market is competitive, with other otic solutions containing ciprofloxacin or fluocinolone acetonide available, but the combination of ciprofloxacin and fluocinolone acetonide has a unique position due to its demonstrated efficacy and safety.

What are the future market projections for this product?

The market is expected to grow due to increasing incidence of ear infections and the need for effective treatments, with potential expansion into new markets and increasing awareness among healthcare providers driving growth.

Sources

  1. Cantor LB, Donnenfeld E, Katz LJ, et al. Penetration of Ofloxacin and Ciprofloxacin Into the Aqueous Humor of Eyes With Functioning Filtering Blebs: A Randomized Trial. Arch Ophthalmol. 2001;119(9):1254–1257. doi:10.1001/archopht.119.9.1254
  2. FDA Clinical PREA - Ciprofloxacin and Fluocinolone acetonide Clinical PREA[2]
  3. Efficacy and Safety of Ciprofloxacin Plus Fluocinolone Acetonide Otic Solution - PubMed[3]
  4. Ciprofloxacin Betaine/Ciprofloxacin Hydrochloride - Patsnap Synapse[4]
  5. Ciprofloxacin and Fluocinolone acetonide Otic Solution - Health Canada[5]

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