CLINICAL TRIALS PROFILE FOR CILOXAN

All Clinical Trials for CILOXAN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04212078 ↗	Intracameral Levofloxacin (0.5%) vs Intracameral Cefuroxime	Recruiting	Santen Pharmaceutical Co., Ltd.	Phase 1/Phase 2	2019-07-29	Endophthalmitis is a clinical diagnosis made when intraocular inflammation involving both posterior and anterior chamber; is attributable to bacterial or fungal infection. It is a serious intraocular inflammatory disorder which can be spread via endogenous or exogenous access into the eye by infecting organism. Exogenous spread usually happens post intraocular surgery or procedure (i.e. cataract, vitrectomy, glaucoma filtration surgery) while endogenous spread is associated with hematogenous spread. The occurrence of endophthalmitis accounts for serious post-operative complication which can lead to severe vision loss and even blindness. There are several studies conducted to ascertain the efficiency of intracameral antibiotic as post-operative endophthalmitis prophylaxis. However, there is limited study in human using intracameral levofloxacin to evaluate its effect.This study is designed to compare between intracameral levofloxacin and intracameral cefuroxime in terms of corneal endothelial cell count and its morphology and central corneal thickness in uncomplicated phacoemulsification surgery
NCT03862170 ↗	Antibiotic Prophylaxis for HDR Brachytherapy in the Treatment of Prostate Cancer	Suspended	CR-CSSS Champlain-Charles-Le Moyne	Phase 3	2015-02-10	Phase III study that aims to evaluate the necessity of prophylactic antibiotics use after HDR brachytherapy in the treatment of prostate adenocarcinomas.
NCT02223338 ↗	Bacterial Resistance in Patients Receiving Post-Intravitreal Injection Antibiotics	Completed	Loma Linda University	N/A	2014-10-01	1. Background: Over 1 million intravitreal injections are performed annually in the United States. The most devastating complication related to these injections is endophthalmitis, with an incidence of 0.02 - 0.1% per injection. Techniques aimed at prevention of this complication have been studied, though emergence rates of antibiotic resistant bacteria in a single clinic population comparing antiseptic technique with iodine vs. use of post-injection second generation fluoroquinolones has not been reported in the literature. 2. Objectives: The purpose of the study is to help determine the best way to prevent infection and limit antibiotic resistance in patients receiving eye injections. 3. Procedures Involved (Research Interventions): After the patient is chosen based on inclusion criteria and agrees to participate in the study, exclusion criteria will be reviewed, cognizance will be determined, informed consent and HIPAA compliance forms will be signed. At this point and prior to the instillation of ophthalmic medications, a Rayon swab will be passed along the inferior fornix of the study eye while the patient looks up and the examiner lowers the lower eyelid. The swab will then be used to inoculate chocolate agar and a blood agar culture plates and a glass slide. These will be brought to the FMO microbiology department for culture and Gram stain. All Staphylococcus aureus and coagulase negative Staphylococcus species identified will be subjected to sensitivity testing using the Gram Positive antibiotic panel available at Loma Linda, with the addition of ciprofloxacin.
NCT01157819 ↗	Safety and Efficacy of Once-Daily Dosing of FoamOtic Cipro Compared to Twice-Daily Dosing of Ciloxan Ear Drops in Patients With Acute External Otitis	Completed	Otic Pharma	Phase 2	2010-07-01	The purpose of this study is to assess the Safety and Efficacy of Foam Otic Cipro (0.3% Ciprofloxacin Otic Foam), used once-daily for 7 days for the treatment of Acute Diffuse Otitis Externa, compared to commercial ear drops used twice daily for 7 days.
NCT00872209 ↗	Safety and Efficacy Study of Foam Otic Cipro Compared to a Standard Solution ( Ciloxan - Alcon Labs ) to Treat Acute Otitis Externa	Completed	Otic Pharma	Phase 1/Phase 2	2009-05-01	The purpose of this study is to assess the Safety and Efficacy of Foam Otic Cipro, a novel medication developed to treat Acute Diffuse Otitis Externa of bacterial origin. The working hypothesis is that Foam Otic Cipro is as effective as registered ear drops.
NCT00855608 ↗	Intravitreal Adalimumab in Refractory Diabetic Retinopathy, Choroidal Neovascularization or Uveitis: A Pilot Study	Unknown status	American University of Beirut Medical Center	Phase 1	2009-03-01	Direct intravitreal administration of medication is the preferred method of treatment for uveitis and retinal vascular disorders. The eye is a self contained organ relatively isolated from the systemic circulation by the tight blood retinal barrier. Effective intraocular drug levels can be achieved with a much smaller amount of medication if injected intravitreally and this also results in minimal systemic exposure to the patient. Preliminary studies have shown that adalimumab may have a positive role in the management of uveitis in humans and can be an effective treatment intravitreally in animal models. No data has been published yet on intravitreal use of adalimumab in human subjects.
NCT00855608 ↗	Intravitreal Adalimumab in Refractory Diabetic Retinopathy, Choroidal Neovascularization or Uveitis: A Pilot Study	Unknown status	Rafic Hariri University Hospital	Phase 1	2009-03-01	Direct intravitreal administration of medication is the preferred method of treatment for uveitis and retinal vascular disorders. The eye is a self contained organ relatively isolated from the systemic circulation by the tight blood retinal barrier. Effective intraocular drug levels can be achieved with a much smaller amount of medication if injected intravitreally and this also results in minimal systemic exposure to the patient. Preliminary studies have shown that adalimumab may have a positive role in the management of uveitis in humans and can be an effective treatment intravitreally in animal models. No data has been published yet on intravitreal use of adalimumab in human subjects.

Clinical Trial Conditions for CILOXAN

Condition Name

Condition Name for CILOXAN
Intervention	Trials
Ear Diseases	2
Otitis	2
Otitis Externa	2
Otorhinolaryngologic Diseases	2

Condition MeSH

Condition MeSH for CILOXAN
Intervention	Trials
Ear Diseases	2
Otorhinolaryngologic Diseases	2
Otitis Externa	2
Otitis	2

Clinical Trial Locations for CILOXAN

Trials by Country

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−

Trials by Country for CILOXAN
Location	Trials
Israel	2
Malaysia	1
Lebanon	1
Canada	1
United States	1

Trials by US State

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−

Trials by US State for CILOXAN
Location	Trials
California	1

Clinical Trial Progress for CILOXAN

Clinical Trial Phase

Clinical Trial Phase for CILOXAN
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	1
Phase 1/Phase 2	2

Clinical Trial Status

Clinical Trial Status for CILOXAN
Clinical Trial Phase	Trials
Completed	3
Recruiting	1
Suspended	1

Clinical Trial Sponsors for CILOXAN

Sponsor Name

Sponsor Name for CILOXAN
Sponsor	Trials
Otic Pharma	2
Loma Linda University	1
CR-CSSS Champlain-Charles-Le Moyne	1

Sponsor Type

Sponsor Type for CILOXAN
Sponsor	Trials
Other	5
Industry	3

Ciloxan: Clinical Trials, Market Analysis, and Projections

Introduction to Ciloxan

Ciloxan, known generically as ciprofloxacin, is a broad-spectrum antibiotic used to treat various bacterial infections. It is available in several formulations, including ophthalmic solutions and otic solutions, each targeting different types of infections.

Clinical Trials Update

Recent clinical trials have focused on the efficacy and safety of ciprofloxacin in combination with other medications, particularly for treating acute otitis externa (AOE).

Efficacy and Safety of Ciprofloxacin Plus Fluocinolone Acetonide

A phase 3 randomized, double-blind, active-controlled clinical trial conducted between August 2017 and September 2018 involved 493 patients with AOE. Participants were randomized to receive either ciprofloxacin plus fluocinolone acetonide, ciprofloxacin alone, or fluocinolone acetonide alone for 7 days.

• Therapeutic Response: At the end of the treatment (visit 3), the therapeutic cure rates were statistically comparable among the groups: 61.2% for ciprofloxacin plus fluocinolone, 53.8% for ciprofloxacin alone, and 44.4% for fluocinolone alone. However, by visit 4 (test of cure), 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 Symptoms: The combination therapy also demonstrated a faster resolution of otalgia (ear pain) compared to the other groups, with a median resolution time of 5.0 days versus 5.9 days for ciprofloxacin alone and 7.7 days for fluocinolone alone[4].

• Safety and Compliance: The study reported high compliance rates across all groups, with minimal discontinuations due to adverse effects. Rescue medication was required in only a small percentage of patients[1].

Key Findings

• The combination of ciprofloxacin and fluocinolone acetonide is efficacious and safe for treating AOE.
• It offers a faster resolution of symptoms and a higher sustained microbiological response compared to monotherapy with either agent[1][4].

Market Analysis

Global Ciprofloxacin Market

The global ciprofloxacin market is experiencing significant growth driven by increasing demand for effective antibiotic treatments.

• Market Size and Growth: As of 2023, the global ciprofloxacin market was valued at USD 1.6 billion and is projected to reach USD 4.9 billion by 2031, growing at a compound annual growth rate (CAGR) of 4.5% from 2024 to 2031[2].

• Segmentation: The market is segmented by application, product type, and geographical regions. North America, Europe, and the Asia-Pacific region are key markets, with North America expected to lead due to robust medical infrastructure and favorable reimbursement policies[2].

Ciprofloxacin Ophthalmic Solution Market

The ciprofloxacin ophthalmic solution market is a significant segment within the broader ciprofloxacin market.

• Market Size and Forecast: In 2022, the global ciprofloxacin ophthalmic solution market was valued at USD 152.24 million and is expected to reach USD 228.92 million by 2030, growing at a CAGR of 5.4% during the forecast period[3][5].

• Regional Growth: North America is the leading region for this market, driven by the high prevalence of eye infections and advanced medical infrastructure. Europe and Latin America also show promising growth due to increasing healthcare investments and research activities[5].

• Dosage and End-Users: The market is segmented by dosage (e.g., 2 drops/30 minutes, 1-2 drops/2 hours) and end-users (hospitals, homecare, specialty clinics). Hospitals were the leading end-users in 2022, and the 1-2 drops/2 hours dosage showed the maximum market share[3][5].

Market Drivers and Challenges

Drivers

• Increasing Prevalence of Infections: The growing rate of bacterial infections, including eye and ear infections, is a major driver for the ciprofloxacin market.
• Advanced Medical Infrastructure: Robust medical infrastructure in regions like North America and Europe facilitates easy access to healthcare, contributing to market growth.
• Favorable Reimbursement Policies: Positive medical reimbursement policies in key regions encourage more people to seek and afford healthcare services, including antibiotic treatments[2][5].

Challenges

• Antibiotic Resistance: The increasing resistance to antibiotics, including ciprofloxacin, poses a significant challenge to the market.
• Regulatory Hurdles: Strict regulatory requirements and the need for continuous clinical trials to ensure safety and efficacy can slow market growth.
• Competition from Alternatives: The presence of other antibiotic treatments and the development of new antimicrobial agents can compete with ciprofloxacin for market share[2][5].

Projections and Future Outlook

Market Growth Projections

• The ciprofloxacin market is expected to continue growing, driven by the increasing demand for effective antibiotic treatments and the expansion of healthcare infrastructure in various regions.
• The ophthalmic solution segment is particularly promising, with a projected CAGR of 5.4% from 2023 to 2030[3][5].

Emerging Opportunities

• Research and Development: Ongoing research and development activities focused on improving the efficacy and safety of ciprofloxacin formulations will continue to drive market growth.
• Expanding into New Markets: There is potential for growth in emerging markets, particularly in regions with improving healthcare infrastructure and increasing healthcare spending[2][5].

Key Takeaways

• Clinical Efficacy: Ciprofloxacin, especially in combination with fluocinolone acetonide, has shown efficacy and safety in treating acute otitis externa.
• Market Growth: The global ciprofloxacin market, including the ophthalmic solution segment, is projected to grow significantly over the next few years.
• Drivers and Challenges: The market is driven by increasing infection rates and advanced medical infrastructure but faces challenges such as antibiotic resistance and regulatory hurdles.

FAQs

What is the current market size of the global ciprofloxacin market?

The global ciprofloxacin market was valued at USD 1.6 billion in 2023[2].

What is the projected growth rate of the ciprofloxacin ophthalmic solution market?

The ciprofloxacin ophthalmic solution market is expected to grow at a CAGR of 5.4% from 2023 to 2030[3][5].

Which region leads in the ciprofloxacin ophthalmic solution market?

North America is the leading region for the ciprofloxacin ophthalmic solution market, driven by robust medical infrastructure and favorable reimbursement policies[5].

What are the key drivers of the ciprofloxacin market?

Key drivers include the increasing prevalence of bacterial infections, advanced medical infrastructure, and favorable medical reimbursement policies[2][5].

What challenges does the ciprofloxacin market face?

Challenges include antibiotic resistance, regulatory hurdles, and competition from alternative treatments[2][5].

Sources

1. JAMA Network Open: "Efficacy and Safety of Ciprofloxacin Plus Fluocinolone Acetonide for Acute Otitis Externa: A Randomized Clinical Trial"[1].
2. Market Research Intellect: "Ciprofloxacin Market Size, Trends and Projections"[2].
3. GlobeNewswire: "Global Ciprofloxacin Ophthalmic Solution Market Size Predicted to Surpass $228.92 Bn Growth by 2030, Growing at a CAGR of 5.4% "[3].
4. PubMed: "Efficacy and Safety of Ciprofloxacin Plus Fluocinolone Acetonide for Acute Otitis Externa"[4].
5. Zion Market Research: "Ciprofloxacin Ophthalmic Solution Market Size, Share, Growth and Forecast"[5].