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Last Updated: January 10, 2025

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CLINICAL TRIALS PROFILE FOR CIPRODEX


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All Clinical Trials for ciprodex

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00956748 ↗ N-Acetylcysteine as an Adjunct for Refractory Chronic Suppurative Otitis Media Withdrawn St. Paul's Hospital, Canada Phase 4 2019-11-29 Chronic suppurative otitis media (CSOM) can be particularly difficult to treat as a number of patients do not respond to routine antibiotic or surgical treatments. The current treatment involves administering combination antibiotic anti-inflammatory ear drops such as Ciprodex (ciprofloxacin 0.3% / dexamethasone 0.1%). Although most patients experience a relief of symptoms, a fraction of patients remain refractory to treatment. Recent findings suggest that the addition of N-acetylcysteine (0.5-2%) to Ciprodex is a superior treatment for otitis media with effusion compared to the use of Ciprodex alone.
NCT01908803 ↗ Proof-of-Concept Study of a Single Application of an Investigational Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes Terminated Alcon Research Phase 2 2013-12-01 The purpose of this study is to evaluate a single application of AL-60371/AL-817 Otic Suspension relative to ototopical CIPRODEX for sustained clinical cure, microbiological success, and time to cessation of otorrhea.
NCT01910155 ↗ A Bioequivalence Study of Two Ciprofloxacin/Dexamethasone Formulations in Patients With Otitis Externa Terminated Novum Pharmaceutical Research Services Phase 3 2013-07-01 The objective of this study is to compare the relative efficacy and safety of the test formulation of ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension (Par Pharmaceutical Companies, Inc.) to the already-marketed formulation CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%) sterile otic suspension (Alcon) in the treatment of acute bacterial otitis externa.
NCT01359098 ↗ Efficacy and Safety of Once-Daily Ciprodexa Otic Foam Compared to Twice-daily Ciprodex Ear Drops in Acute Otitis Externa Completed Otic Pharma Phase 2 2011-07-01 The purpose of this study is to assess the Safety and Efficacy of Ciprodexa Foam (0.3% Ciprofloxacin, 0.1% Dexamethasone Otic Foam), used once-a-day for 7 days for the treatment of Acute Diffuse Otitis Externa, compared to Ciprodex otic suspension used twice daily for 7 days.
NCT01027494 ↗ Topical Treatment of Acute Otitis Media Through Tympanostomy Tubes (AOMT) and Its Effect on Microbial Flora Completed Alcon Research 2009-12-01 The purpose of this observational study was to evaluate the effects of a topical fluoroquinolone (antibiotic) instilled into the otic (ear) canal to treat Acute Otitis Media through Tympanostomy Tubes (AOMT) on selected bacterial species on the skin near the ear, in the nose, and in the throat.
NCT00961675 ↗ FST-201 in the Treatment of Acute Otitis Externa Completed Shire Phase 3 2009-08-31 The objective of this study is to evaluate the efficacy of FST-201 compared to Ciprodex in the treatment of acute otitis externa. This study will be conducted at one site, the Lyndon B. Johnson (LBJ) Tropical Medical Center, Department of Otolaryngology, in Pago Pago, American Samoa.
NCT00945802 ↗ FST-201 In The Treatment of Acute Otitis Externa Terminated Shire Phase 3 2009-07-31 The objective of this study is to evaluate the efficacy of FST-201 compared to Ciprodex in the treatment of acute otitis externa. This trial is designed to enable filing of a New Drug Application in support of FST-201 for the indication of acute otitis externa.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 7 of 7 entries

Clinical Trial Conditions for ciprodex

Condition Name

3222000.511.522.53Acute Otitis ExternaOtitis ExternaOtorrheaAcute Otitis Media[disabled in preview]
Condition Name for ciprodex
Intervention Trials
Acute Otitis Externa 3
Otitis Externa 2
Otorrhea 2
Acute Otitis Media 2
[disabled in preview] 0
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Condition MeSH

955100123456789OtitisOtitis MediaOtitis ExternaSuppuration[disabled in preview]
Condition MeSH for ciprodex
Intervention Trials
Otitis 9
Otitis Media 5
Otitis Externa 5
Suppuration 1
[disabled in preview] 0
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Clinical Trial Locations for ciprodex

Trials by Country

+
Trials by Country for ciprodex
Location Trials
United States 51
Puerto Rico 2
American Samoa 1
Canada 1
Israel 1
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Trials by US State

+
Trials by US State for ciprodex
Location Trials
Texas 4
Florida 4
Virginia 3
Oregon 3
Ohio 3
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Clinical Trial Progress for ciprodex

Clinical Trial Phase

22.2%55.6%22.2%0-0.500.511.522.533.544.555.5Phase 4Phase 3Phase 2[disabled in preview]
Clinical Trial Phase for ciprodex
Clinical Trial Phase Trials
Phase 4 2
Phase 3 5
Phase 2 2
[disabled in preview] 0
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Clinical Trial Status

40.0%40.0%20.0%000.511.522.533.54CompletedTerminatedWithdrawn[disabled in preview]
Clinical Trial Status for ciprodex
Clinical Trial Phase Trials
Completed 4
Terminated 4
Withdrawn 2
[disabled in preview] 0
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Clinical Trial Sponsors for ciprodex

Sponsor Name

trials011223344556Novum Pharmaceutical Research ServicesPar Pharmaceutical, Inc.Shire[disabled in preview]
Sponsor Name for ciprodex
Sponsor Trials
Novum Pharmaceutical Research Services 2
Par Pharmaceutical, Inc. 2
Shire 2
[disabled in preview] 5
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Sponsor Type

83.3%16.7%0-101234567891011IndustryOther[disabled in preview]
Sponsor Type for ciprodex
Sponsor Trials
Industry 10
Other 2
[disabled in preview] 0
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Ciprodex Market Analysis and Financial Projection

Ciprodex: Clinical Trials, Market Analysis, and Projections

Introduction

Ciprodex, a combination of ciprofloxacin and dexamethasone (though often referred to in the context of ciprofloxacin and fluocinolone acetonide in clinical trials), is a potent antibiotic and anti-inflammatory otic solution used primarily for the treatment of acute otitis externa (AOE) and other bacterial infections of the ear. This article delves into the recent clinical trials, market analysis, and future projections for Ciprodex.

Clinical Trials: Efficacy and Safety

Recent clinical trials have provided valuable insights into the efficacy and safety of ciprofloxacin plus fluocinolone acetonide, a formulation similar to Ciprodex. A randomized clinical trial involving 493 patients compared the therapeutic outcomes of ciprofloxacin plus fluocinolone acetonide against ciprofloxacin alone and fluocinolone acetonide alone[1][4].

  • Therapeutic Cure Rates: At visit 3, the therapeutic cure rates were statistically comparable among the three groups: 61.2% for ciprofloxacin plus fluocinolone, 53.8% for ciprofloxacin, and 44.4% for fluocinolone. However, by visit 4, the combination of ciprofloxacin plus fluocinolone showed a significantly superior therapeutic response compared to ciprofloxacin alone (87.4% vs 75.8%, P = .04)[1][4].
  • Resolution of Otalgia: Patients treated with ciprofloxacin plus fluocinolone experienced a statistically faster resolution of otalgia, with a median of 5.0 days compared to 5.9 days for ciprofloxacin and 7.7 days for fluocinolone[4].
  • Microbiological Response: The combination also demonstrated a superior sustained microbiological response compared to both ciprofloxacin and fluocinolone alone[4].

Safety Profile

The safety profile of ciprofloxacin plus fluocinolone acetonide was favorable, with no significant differences in adverse events among the treatment groups. The study reported that 26 patients discontinued the study, with compliance rates being high across all groups (96.4% for ciprofloxacin plus fluocinolone, 95.9% for ciprofloxacin, and 97.0% for fluocinolone)[1].

Market Analysis

Current Market Size and Growth

The global ciprofloxacin ophthalmic solution market, which includes similar formulations like Ciprodex, was valued at USD 160.46 million in 2023. This market is projected to grow to USD 244.40 million by 2031, with a Compound Annual Growth Rate (CAGR) of 5.4% during the forecast period of 2024 to 2031[3].

Regional Market Dynamics

  • North America: This region is expected to dominate the market due to its advanced healthcare infrastructure and robust medical facilities. The widespread adoption of ciprofloxacin ophthalmic solutions in North America drives significant market growth[3].
  • Asia-Pacific: This region is anticipated to experience significant growth driven by increased investments in healthcare infrastructure and rising awareness about eye and ear health. This surge in demand for advanced treatments will contribute to the market's expansion[3].

Promotional Activities and Physician Engagement

Reports on Ciprodex's promotional activities in 2018 and 2019 highlight the extensive engagement with physicians. For instance, in 2018, over 2,100 paid interactions were made with 1,600 physicians, and in 2019, over 2,000 interactions were made with 1,500 physicians. These interactions included sales rep detailing, physician education, and paid speaking engagements, indicating a strong promotional strategy to increase physician awareness and adoption of Ciprodex[2][5].

Market Segmentation

The market for ciprofloxacin ophthalmic solutions, including Ciprodex, is segmented based on several factors:

  • Type: Branded and generic formulations.
  • Dosage: Various dosing regimens such as 1-2 drops every 2 hours, 2 drops every 15 minutes, and 2 drops every 30 minutes.
  • Application: Treatments for corneal ulcers, bacterial conjunctivitis, and other ocular conditions.
  • End-Users: Hospitals, homecare, specialty clinics, and others.
  • Distribution Channel: Hospital pharmacy, online pharmacy, and retail pharmacy[3].

Future Projections

Market Growth Drivers

The market for ciprofloxacin ophthalmic solutions is driven by several key factors:

  • Advancements in Formulations: Continuous research and innovation lead to enhanced formulations and delivery mechanisms, improving efficacy and patient experience.
  • Increasing Healthcare Investments: Growing investments in healthcare infrastructure, particularly in the Asia-Pacific region, are expected to drive market growth.
  • Rising Awareness: Increased awareness about eye and ear health contributes to the demand for advanced treatments like Ciprodex[3].

Challenges and Opportunities

While the market is poised for growth, there are challenges to consider:

  • Regulatory Frameworks: Strict regulatory requirements can impact the approval and adoption of new formulations.
  • Competition: The presence of both branded and generic formulations in the market can lead to competitive pricing and market share dynamics.
  • Patient Epidemiology: Changes in patient demographics and disease prevalence can influence market demand[3].

Key Takeaways

  • Clinical Efficacy: Ciprofloxacin plus fluocinolone acetonide has shown promising results in clinical trials, particularly in treating acute otitis externa.
  • Market Growth: The global market for ciprofloxacin ophthalmic solutions is projected to grow significantly, driven by advancements in formulations and increasing healthcare investments.
  • Regional Dynamics: North America and the Asia-Pacific region are key markets, with the latter expected to grow substantially due to rising healthcare investments.
  • Promotional Strategies: Extensive promotional activities, including physician engagement, are crucial for market penetration.

FAQs

What is Ciprodex used for?

Ciprodex is primarily used for the treatment of acute otitis externa (AOE) and other bacterial infections of the ear.

What are the key findings from recent clinical trials on Ciprodex?

Recent clinical trials have shown that ciprofloxacin plus fluocinolone acetonide is efficacious and safe, with superior therapeutic and microbiological responses compared to ciprofloxacin alone in some measures.

What is the projected market size for ciprofloxacin ophthalmic solutions by 2031?

The global market for ciprofloxacin ophthalmic solutions is projected to reach USD 244.40 million by 2031.

Which regions are expected to drive market growth for Ciprodex?

North America and the Asia-Pacific region are expected to be key drivers of market growth, with the latter experiencing significant growth due to increased healthcare investments.

What are the main factors driving the market growth for ciprofloxacin ophthalmic solutions?

Market growth is driven by advancements in formulations, increasing healthcare investments, and rising awareness about eye and ear health.

Sources

  1. JAMA Network Open: Efficacy and Safety of Ciprofloxacin Plus Fluocinolone Acetonide for Acute Otitis Externa.
  2. MDDetails: Ciprodex 2018 U.S. Promotional Audit Report.
  3. Data Bridge Market Research: Global Ciprofloxacin Ophthalmic Solution Market Size & Growth Forecast.
  4. PubMed: Efficacy and Safety of Ciprofloxacin Plus Fluocinolone Acetonide for Acute Otitis Externa.
  5. MDDetails: Ciprodex 2019 U.S. Promotional Audit Report.

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