CLINICAL TRIALS PROFILE FOR QUIXIN

All Clinical Trials for QUIXIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04502095 ↗	Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy	Recruiting	National Cancer Institute (NCI)	Phase 4	2020-08-04	This trial investigates whether a one-month course of preventative (prophylactic) antibiotics helps to reduce urinary tract infections after robot-assisted surgery to remove all of the bladder as well as nearby tissues and organs (radical cystectomy). Urinary tract infections are a common occurrence after robot-assisted radical cystectomy. Antibiotics such as trimethoprim-sulfamethoxazole or nitrofurantoin may prevent or control infections in patients with urinary tract infection and may help improve their response to radical cystectomy. Information gained from this study may help researchers to predict patient complications and identify better ways to manage these complications.
NCT04502095 ↗	Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy	Recruiting	Roswell Park Cancer Institute	Phase 4	2020-08-04	This trial investigates whether a one-month course of preventative (prophylactic) antibiotics helps to reduce urinary tract infections after robot-assisted surgery to remove all of the bladder as well as nearby tissues and organs (radical cystectomy). Urinary tract infections are a common occurrence after robot-assisted radical cystectomy. Antibiotics such as trimethoprim-sulfamethoxazole or nitrofurantoin may prevent or control infections in patients with urinary tract infection and may help improve their response to radical cystectomy. Information gained from this study may help researchers to predict patient complications and identify better ways to manage these complications.
NCT01371656 ↗	Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation	Completed	National Cancer Institute (NCI)	Phase 3	2011-09-01	This randomized phase III trial studies how well levofloxacin works in preventing infection in young patients with acute leukemia receiving chemotherapy or undergoing stem cell transplant. Giving antibiotics may be effective in preventing or controlling early infection in patients receiving chemotherapy or undergoing stem cell transplant for acute leukemia. It is not yet known whether levofloxacin is effective in preventing infection.
NCT01371656 ↗	Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation	Completed	Children's Oncology Group	Phase 3	2011-09-01	This randomized phase III trial studies how well levofloxacin works in preventing infection in young patients with acute leukemia receiving chemotherapy or undergoing stem cell transplant. Giving antibiotics may be effective in preventing or controlling early infection in patients receiving chemotherapy or undergoing stem cell transplant for acute leukemia. It is not yet known whether levofloxacin is effective in preventing infection.

Clinical Trial Conditions for QUIXIN

Condition Name

Condition Name for QUIXIN
Intervention	Trials
Recurrent Childhood Acute Myeloid Leukemia	1
Refractory Bladder Carcinoma	1
Secondary Acute Myeloid Leukemia	1
Acute Leukemias of Ambiguous Lineage	1

Condition MeSH

Condition MeSH for QUIXIN
Intervention	Trials
Infections	2
Infection	2
Communicable Diseases	2
Leukemia, Myeloid	1

Clinical Trial Locations for QUIXIN

Trials by Country

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−

Trials by Country for QUIXIN
Location	Trials
United States	34
Canada	5

Trials by US State

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−

Trials by US State for QUIXIN
Location	Trials
New York	2
Florida	1
District of Columbia	1
Delaware	1
Connecticut	1

Clinical Trial Progress for QUIXIN

Clinical Trial Phase

Clinical Trial Phase for QUIXIN
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1

Clinical Trial Status

Clinical Trial Status for QUIXIN
Clinical Trial Phase	Trials
Completed	1
Recruiting	1

Clinical Trial Sponsors for QUIXIN

Sponsor Name

Sponsor Name for QUIXIN
Sponsor	Trials
National Cancer Institute (NCI)	2
Children's Oncology Group	1
Roswell Park Cancer Institute	1

Sponsor Type

Sponsor Type for QUIXIN
Sponsor	Trials
NIH	2
Other	2

QUIXIN (Levofloxacin Ophthalmic Solution): Clinical Trials, Market Analysis, and Projections

Introduction

QUIXIN, an ophthalmic solution containing levofloxacin, is a fluoroquinolone antibiotic used to treat bacterial conjunctivitis and other ocular infections. This article will delve into the clinical trials, market analysis, and future projections for QUIXIN.

Clinical Trials Overview

Efficacy in Bacterial Conjunctivitis

Clinical trials have demonstrated the efficacy of QUIXIN in treating bacterial conjunctivitis. In randomized, double-masked, multicenter controlled clinical trials, QUIXIN showed a clinical cure rate of 79% in patients treated for 5 days. These trials involved administering the solution every 2 hours on days 1-2 and every 4 hours on days 3-5. The microbial outcomes indicated an eradication rate for presumed pathogens of 90%[1][4].

Clinical Cure Rates and Microbial Outcomes

The clinical trials highlighted that QUIXIN is highly effective against a broad spectrum of Gram-positive and Gram-negative ocular pathogens. The clinical cure rates were significant, with 79% of patients achieving clinical cures by the final study visit day (days 6-10)[1].

Adverse Events

While QUIXIN has shown strong efficacy, it is also important to consider the adverse events associated with its use. Common adverse events included headache and taste disturbance, occurring in approximately 8-10% of patients. Less frequent adverse events included decreased/blurred vision, diarrhea, dyspepsia, fever, and ocular pain/discomfort[2].

Pharmacokinetics

Plasma and Tear Concentrations

Studies on the pharmacokinetics of QUIXIN have shown that the levofloxacin concentration in plasma remains very low compared to oral doses. The mean levofloxacin concentration in plasma ranged from 0.86 ng/mL on Day 1 to 2.05 ng/mL on Day 15, which is more than 1,000 times lower than those reported after standard oral doses of levofloxacin[1].

In tears, the mean levofloxacin concentrations were significantly higher, ranging from 34.9 to 221.1 mcg/mL during the 60-minute period following a single dose. These concentrations decreased to 17.0 and 6.6 mcg/mL at 4 and 6 hours postdose, respectively[1].

Market Analysis

FDA Approval and Distribution

QUIXIN was approved by the FDA on August 18, 2000, for the treatment of bacterial conjunctivitis. It is distributed exclusively by VISTAKON Pharmaceuticals, LLC, in the United States, as part of Santen Pharmaceutical Co., Ltd.'s portfolio of ophthalmic products[2][5].

Market Position

QUIXIN competes in the ophthalmic antibiotic market, which is dominated by fluoroquinolones due to their broad-spectrum activity and efficacy. The high concentration of levofloxacin in QUIXIN, particularly the 0.5% solution, positions it as a strong competitor against other ophthalmic antibiotics.

Comparative Analysis with IQUIX

IQUIX, another levofloxacin ophthalmic solution with a 1.5% concentration, is also developed by Santen and approved for the treatment of bacterial corneal ulcers. While IQUIX has a higher concentration of levofloxacin, QUIXIN's 0.5% solution is specifically indicated for bacterial conjunctivitis. The clinical cure rates for IQUIX ranged from 73% to 87%, which is comparable to QUIXIN's efficacy[2].

Market Projections

Growing Demand for Ophthalmic Antibiotics

The demand for ophthalmic antibiotics is expected to grow due to the increasing incidence of bacterial eye infections and the need for effective treatments. QUIXIN, with its proven efficacy and safety profile, is well-positioned to capture a significant share of this market.

Competitive Landscape

The ophthalmic antibiotic market is competitive, with several fluoroquinolones available. However, QUIXIN's strong clinical trial data and the absence of preservatives like benzalkonium chloride (BAK) make it an attractive option for both physicians and patients[2].

Regulatory Environment

Regulatory approvals and compliance are crucial for the continued success of QUIXIN. Santen's strong track record in obtaining FDA approvals and maintaining regulatory compliance ensures that QUIXIN will remain a viable treatment option in the market.

Future Developments and Challenges

Resistance and Safety Concerns

One of the significant challenges facing fluoroquinolones, including QUIXIN, is the development of antibiotic resistance. Continuous monitoring and research are necessary to address this issue. Additionally, safety concerns such as potential toxicity and adverse events need to be carefully managed[3].

Emerging Trends and Innovations

The field of ophthalmic antibiotics is evolving, with new drugs and formulations being developed. For instance, levonadifloxacin and ozenoxacin, which have resistance suppression properties, are recent examples of innovative antibiotics. QUIXIN must adapt to these emerging trends to remain competitive[3].

Key Takeaways

• Efficacy: QUIXIN has demonstrated a high clinical cure rate of 79% in treating bacterial conjunctivitis.
• Pharmacokinetics: The solution achieves high concentrations in tears while maintaining low plasma levels.
• Market Position: QUIXIN is a strong competitor in the ophthalmic antibiotic market due to its efficacy and safety profile.
• Regulatory Compliance: Santen's strong regulatory track record supports the continued market presence of QUIXIN.
• Future Challenges: Managing antibiotic resistance and safety concerns are critical for the long-term success of QUIXIN.

FAQs

What is QUIXIN used for?

QUIXIN is used for the treatment of bacterial conjunctivitis.

What is the concentration of levofloxacin in QUIXIN?

QUIXIN contains 0.5% levofloxacin.

What are the common adverse events associated with QUIXIN?

Common adverse events include headache, taste disturbance, decreased/blurred vision, and ocular pain/discomfort.

How does QUIXIN compare to IQUIX?

QUIXIN is specifically indicated for bacterial conjunctivitis with a 0.5% levofloxacin concentration, while IQUIX has a 1.5% concentration and is indicated for bacterial corneal ulcers.

What are the future challenges for QUIXIN?

Future challenges include managing antibiotic resistance, addressing safety concerns, and adapting to emerging trends and innovations in ophthalmic antibiotics.

Sources

1. RxList: Quixin (Levofloxacin Ophthalmic Solution 0.5%) - RxList
2. Santen: Santen Receives FDA Approval of IQUIX
3. uu.diva-portal.org: Recent developments of topoisomerase inhibitors
4. PubMed: A phase III, placebo controlled clinical trial of 0.5% levofloxacin ...
5. FDA: Drug Approval Package: Quixin (levofloxacin ophthalmic solution) Sterile