CLINICAL TRIALS PROFILE FOR LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE

All Clinical Trials for Lidocaine Hydrochloride Preservative Free

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00468429 ↗	Subconjunctival Bevacizumab to Prevent Bleb Failure After Glaucoma Filtration Surgery	Unknown status	Grewal Eye Institute	Phase 4	2007-05-01	This study analyzes the safety and efficacy of off-label Subconjunctival Injection of bevacizumab (Avastin) versus 0.02% mitomycin C (MMC) for preventing bleb failure following glaucoma filtration surgery.
NCT00948103 ↗	The Interest of the Nitrous Oxide During Intravesical Injection of Botulinum Toxin A	Completed	Assistance Publique - Hôpitaux de Paris	Phase 3	2008-09-01	Second line treatment for detrusor hyperreflexia is the intravesical BTX-A injections. First 300 units Botox are diluted with 30 ml of preservative-free saline. Using a rigid cystoscope and an injection needle, BTX-A is injected into 30 sites within the detrusor muscle. The used of KALINOX® (50% nitrous oxide and oxygen) inhalation has demonstrated analgesic efficacy in various procedures (obstetric, liver biopsy, transrectal ultrasound guided prostate biopsy, emergency) The aim of this study is to investigate the safety and efficacy of analgesia with N2O/O2 inhalation for detrusor BTX-A injections using a rigid cystoscope.
NCT01905137 ↗	Botulinum Toxin Type A Versus Saline Trigger Point Injections for Myofascial Pelvic Pain	Unknown status	Allergan	N/A	2013-07-01	The purpose of this study is to determine whether there is a change in patient-reported pelvic pain following pelvic floor injections of 200 units of Botox compared with 20cc of normal saline.
NCT01905137 ↗	Botulinum Toxin Type A Versus Saline Trigger Point Injections for Myofascial Pelvic Pain	Unknown status	Boston Urogynecology Associates	N/A	2013-07-01	The purpose of this study is to determine whether there is a change in patient-reported pelvic pain following pelvic floor injections of 200 units of Botox compared with 20cc of normal saline.
NCT02196441 ↗	Evaluation of Deep Topical Fornix Nerve Block Versus Topical Anaesthesia Procedure	Unknown status	Cairo University	N/A	2014-08-01	General anaesthesia now a days is not the first choice in phakic intra ocular lens surgery (Phakic IOL) , the short duration of the surgery, general anaesthesia complications, decrease the length of hospital stay and decreasing the costs direct the interest to the regional anaesthesia By the time the traditional retro and peribulbar injections recede to a newer techniques that is safer and cheaper, sub tenon's block using a blunt needle took over due to the more safety profile Even though, still serious problems can occur specially in patients with long axial length. Deep topical fornix nerve block anaesthesia (DTFNB) and topical anaesthesia gradually took over with promising and successful results, decreasing length of hospital stay and increasing patient satisfaction and fewer margins of complications. In this study the investigators compared topical anaesthesia alone with DTFNBA in patients undergoing posterior chamber phakic IOL surgery (Visian ICL).
NCT02413268 ↗	Topical Nitroglycerin To Prevent Radial Artery Occlusion After Transradial Access: NTP-RAO Trial	Unknown status	Total Cardiovascular Solutions	Phase 3	2016-03-01	A randomized comparison of topical nitroglycerin versus placebo gel for prevention of radial artery occlusion after transradial catheterization.
NCT02608489 ↗	Clinical Effects and Safety of 3% Diquafosol After Cataract Surgery	Completed	Soonchunhyang University Hospital	N/A	2014-01-01	The purpose of this study is determine whether 3% diquafosol and 0.1% sodium hyaluronate are effective and safe in the treatment of patients with dry eye after cataract surgery.

Clinical Trial Conditions for Lidocaine Hydrochloride Preservative Free

Condition Name

Condition Name for Lidocaine Hydrochloride Preservative Free
Intervention	Trials
Pain	2
Eyelid Deformity	1
Ophthalmology	1
Transradial Catheterization, Radial Artery Occlusion	1

Condition MeSH

Condition MeSH for Lidocaine Hydrochloride Preservative Free
Intervention	Trials
Pain, Postoperative	2
Dry Eye Syndromes	1
Hypotension	1
Cataract	1

Clinical Trial Locations for Lidocaine Hydrochloride Preservative Free

Trials by Country

Trials by Country for Lidocaine Hydrochloride Preservative Free
Location	Trials
United States	20
India	2
Pakistan	1
France	1
Egypt	1

Trials by US State

Trials by US State for Lidocaine Hydrochloride Preservative Free
Location	Trials
California	5
Ohio	2
Massachusetts	2
Wisconsin	1
West Virginia	1

Clinical Trial Progress for Lidocaine Hydrochloride Preservative Free

Clinical Trial Phase

Clinical Trial Phase for Lidocaine Hydrochloride Preservative Free
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	2
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Lidocaine Hydrochloride Preservative Free
Clinical Trial Phase	Trials
Completed	5
Recruiting	5
Unknown status	4

Clinical Trial Sponsors for Lidocaine Hydrochloride Preservative Free

Sponsor Name

Sponsor Name for Lidocaine Hydrochloride Preservative Free
Sponsor	Trials
Assistance Publique - Hôpitaux de Paris	1
Fayoum University Hospital	1
Allergan	1

Sponsor Type

Sponsor Type for Lidocaine Hydrochloride Preservative Free
Sponsor	Trials
Other	17
Industry	2

Lidocaine Hydrochloride Preservative Free: Clinical Trials, Market Analysis, and Projections

Introduction

Lidocaine hydrochloride, a widely used local anesthetic and anti-arrhythmic drug, has been a cornerstone in medical practice for decades. The preservative-free formulation of lidocaine hydrochloride is particularly important for certain medical applications, especially where preservatives could be harmful. Here, we will delve into the current state of clinical trials, market analysis, and future projections for preservative-free lidocaine hydrochloride.

Clinical Use and Nominations

Lidocaine hydrochloride has been nominated for inclusion on the 503B Bulks List by several organizations, including Pentec Health, the Specialty Sterile Pharmaceutical Society (SSPS), US Compounding Pharmacy, Pine Pharmaceuticals, and the Outsourcing Facilities Association (OFA). This nomination highlights the need for a bulk drug substance to produce preservative-free products, which is crucial for certain patient populations[1].

Current and Historic Use

Lidocaine hydrochloride is available in various forms, including topical, transdermal, and rectal routes of administration (ROA). It is also available as an over-the-counter (OTC) product in the US. The drug has a current United States Pharmacopeia (USP) monograph, ensuring its quality and safety standards are met[1].

Clinical Trials and Safety

Recent clinical studies have focused on the safety and efficacy of preservative-free lidocaine hydrochloride. For instance, a study on intracameral injections of preservative-free lidocaine hydrochloride in dogs showed no significant endothelial cell loss and established the safety of such injections. This study also evaluated the mydriatic effect of intracameral lidocaine, which is crucial for ophthalmic procedures[4].

Mydriatic Effect Study

A double-blinded, randomized crossover trial was conducted to evaluate the mydriatic effect of intracameral injections of 1% and 2% preservative-free lidocaine hydrochloride solutions. The study found that lidocaine hydrochloride solutions did not cause significant endothelial cell loss and were safe for use in ophthalmic procedures[4].

Market Analysis

The lidocaine hydrochloride market is poised for significant growth, driven by several key factors.

Market Size and Growth

The global lidocaine hydrochloride market is valued at USD 512.70 million in 2023 and is expected to grow at a Compound Annual Growth Rate (CAGR) of 5.7% to reach USD 838.6 million by 2032. This growth is attributed to the increasing demand for pain management solutions, particularly among the aging population[3].

COVID-19 Impact

The COVID-19 pandemic had a notable impact on the market due to the potential anesthetic and anti-inflammatory properties of lidocaine. Nebulized lidocaine was proposed as a beneficial treatment for reducing cytokines and improving outcomes in COVID-19 patients, which boosted market growth during the pandemic period[2][5].

Market Drivers

• Diverse Formulations: The market is driven by the availability of lidocaine hydrochloride in various formulations such as creams and injections, which cater to a wide range of medical needs.
• Advancements in Drug Delivery Technologies: Innovations in drug delivery have enhanced the potency and workability of lidocaine hydrochloride, contributing to market growth.
• Increasing Surgical Procedures: The escalation in minimally invasive surgical processes and the rise in cosmetic procedures are significant drivers of the market[3].

Market Segmentation

The lidocaine hydrochloride market is segmented based on dosage, application, distribution channel, and region. North America dominated the market in 2023, with other regions also showing significant growth potential[3].

Market Projections

Future Growth

The market is expected to continue growing steadily, driven by the increasing number of surgical and cosmetic procedures globally. The relaxation of strict regulations on surgical procedures post-pandemic and the resumption of healthcare services are also expected to boost demand for lidocaine hydrochloride[5].

Emerging Trends

• Pain Management: The growing need for systematic pain management solutions, especially among the aging population, will continue to drive the market.
• Cosmetic and Dental Procedures: The rise in cosmetic and dental procedures will further increase the demand for lidocaine hydrochloride.
• Innovative Products: The introduction of new products by key market players, demonstrating safety and efficacy, will enhance market growth[3].

Key Takeaways

• Lidocaine hydrochloride is nominated for inclusion on the 503B Bulks List to ensure availability of preservative-free products.
• Clinical trials have established the safety and efficacy of preservative-free lidocaine hydrochloride in various medical applications.
• The market is expected to grow at a CAGR of 5.7% to reach USD 838.6 million by 2032.
• Key drivers include diverse formulations, advancements in drug delivery technologies, and increasing surgical procedures.
• The market is segmented by dosage, application, distribution channel, and region, with North America being a dominant market.

FAQs

What is the current market size of lidocaine hydrochloride?

The global lidocaine hydrochloride market is currently valued at USD 512.70 million in 2023[3].

What is the projected growth rate of the lidocaine hydrochloride market?

The market is expected to grow at a CAGR of 5.7% to reach USD 838.6 million by 2032[3].

What are the key drivers of the lidocaine hydrochloride market?

Key drivers include diverse formulations, advancements in drug delivery technologies, and the increasing number of surgical and cosmetic procedures[3].

How did COVID-19 impact the lidocaine hydrochloride market?

COVID-19 boosted market growth due to the potential anesthetic and anti-inflammatory properties of lidocaine, particularly in treating severe respiratory symptoms in COVID-19 patients[2][5].

What are the common applications of preservative-free lidocaine hydrochloride?

Common applications include ophthalmic procedures, pain management, and various surgical and cosmetic procedures[1][3].

Sources

1. University of Maryland, Baltimore. Lidocaine hydrochloride - Summary Report.
2. Mordor Intelligence. Lidocaine Hydrochloride Market - Share, Trends & Size.
3. GlobeNewswire. Global Lidocaine Hydrochloride Market Size/Share Value.
4. AVMA Journals. Evaluation of the mydriatic effect of intracameral lidocaine.
5. Mordor Intelligence. Lidocaine Hydrochloride Market Size - Mordor Intelligence.

Last updated: 2025-01-01