CLINICAL TRIALS PROFILE FOR BRILLIANT BLUE G

All Clinical Trials for BRILLIANT BLUE G

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01820520 ↗	Safety and Efficacy of Double Staining With Brilliant Blue G for Macular Surgery	Unknown status	Asociación para Evitar la Ceguera en México	Phase 3	2013-01-01	Study designed to evaluate the safety and efficacy of double staining with brilliant blue G 0.025% as an adjuvant to macular surgery. Patients undergoing surgery for macular hole or epiretinal membrane will be included. Safety will be evaluated by optic coherence tomography, pattern reversal electroretinogram and multifocal electroretinogram.
NCT00738413 ↗	Iron Balance Study of Deferasirox, Deferoxamine and the Combination of Both	Unknown status	Weill Medical College of Cornell University	Phase 1/Phase 2	2008-08-01	Subjects with thalassemia major require regular transfusion therapy to sustain life. The iron present in the transfused blood remains in the body where it can cause a variety of organ dysfunctions. Lifelong iron chelation therapy is needed to maintain iron balance but its effectiveness varies greatly. Like that of deferoxamine (Desferal, DFO) the mainstay of chelation therapy for 30 years, the effectiveness of deferasirox (Exjade, ICL670), the newly approved, orally effective iron chelating drug, is not satisfactory in all subjects. Even with good compliance, the iron excretion induced by a given drug exhibits wide subject-to-subject variability. There is often persistent iron overload of extra hepatic tissues such as the heart and pancreas leading to cardiac disease and diabetes. Combining the drugs may be a better approach in those subjects at increased risk. The iron balance studies proposed will permit an assessment of the potential of such a combination to place subjects in net negative iron balance and the relative effectiveness of the combination in relation to that of the individual drugs, an additive effect being expected. With such information, physicians will be able to design individualized chelation regimens that maximize effectiveness while minimizing side effects by adjusting the ratio and/or the dosing schedule of the two drugs.
NCT01718314 ↗	Comparison of Sublingual Misoprostol Versus Lidocaine Spray for Hysteroscopy	Completed	Dr. Sami Ulus Children's Hospital	N/A	2008-03-01	Hysteroscopy is an instrument to visualize the interior walls of uterus (womb) and it enables the doctor to do minor operative procedures. Although it causes little discomfort, sometimes it may be disturbing for the patient. This pain is usually perceived during the passage of the instrument through the cervix (neck of the womb). The investigators would like to minimize this pain by two drugs: Misoprotol and lidocaine

Clinical Trial Conditions for BRILLIANT BLUE G

Condition Name

Condition Name for BRILLIANT BLUE G
Intervention	Trials
Macular Hole	2
Pain During Hysteroscopy	1
Plaque	1

Condition MeSH

Condition MeSH for BRILLIANT BLUE G
Intervention	Trials
Retinal Perforations	2
Thalassemia	1
Gingivitis	1

Clinical Trial Locations for BRILLIANT BLUE G

Trials by Country

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Trials by Country for BRILLIANT BLUE G
Location	Trials
China	5
United States	1
Mexico	1
Turkey	1
Canada	1

Trials by US State

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−

Trials by US State for BRILLIANT BLUE G
Location	Trials
New York	1

Clinical Trial Progress for BRILLIANT BLUE G

Clinical Trial Phase

Clinical Trial Phase for BRILLIANT BLUE G
Clinical Trial Phase	Trials
Phase 3	3
Phase 1/Phase 2	1
N/A	3

Clinical Trial Status

Clinical Trial Status for BRILLIANT BLUE G
Clinical Trial Phase	Trials
Completed	3
Unknown status	2
Withdrawn	1

Clinical Trial Sponsors for BRILLIANT BLUE G

Sponsor Name

Sponsor Name for BRILLIANT BLUE G
Sponsor	Trials
Weill Medical College of Cornell University	1
Dr. Sami Ulus Children's Hospital	1
Asociación para Evitar la Ceguera en México	1

Sponsor Type

Sponsor Type for BRILLIANT BLUE G
Sponsor	Trials
Other	4
Industry	3

Brilliant Blue G: Clinical Trials, Market Analysis, and Projections

Introduction

Brilliant Blue G, also known as Brilliant Blue FCF when used in food and cosmetics, is a synthetic dye with diverse applications, particularly in ophthalmology and the food industry. This article delves into the clinical trials, safety profile, market analysis, and future projections of Brilliant Blue G, especially in its ophthalmic use.

Clinical Trials and Safety Profile

Ophthalmic Use

Brilliant Blue G has been extensively studied for its use in ophthalmologic surgical procedures, particularly for staining the internal limiting membrane (ILM). Clinical trials have demonstrated its safety and efficacy in this context.

• Biocompatibility and Toxicity: Studies have shown that Brilliant Blue G has a low potential for toxicity. In rat models, it did not induce significant changes in membrane permeability or mitochondrial membrane potential, and it did not cause apoptotic cell death or necrosis. Instead, it exerted a cytostatic effect due to P2X7 receptor antagonism, leading to reduced cell proliferation[1][4].
• Adverse Events: Clinical trials reported minimal adverse events associated with Brilliant Blue G. The dye has a relatively safe profile, with no detectable toxic effects observed in animal models even at high concentrations[1][4].

Visualization and Surgical Safety

The use of Brilliant Blue G improves the visualization of the internal limiting membrane, which is crucial for certain surgical procedures. This enhanced visualization is expected to improve the safety and outcomes of these surgeries[4].

Market Analysis

Current Market Status

While Brilliant Blue G is primarily discussed in the context of ophthalmology, its market analysis is closely tied to the broader synthetic dye market, particularly the Brilliant Blue FCF market.

• Global Market Size: The global Brilliant Blue FCF colors market, which includes Brilliant Blue G, was estimated to be around US$ 53.8 million in 2022. This market is projected to grow at a CAGR of 4.8% from 2022 to 2032, reaching a valuation of US$ 97.2 million by 2032[2][5].

Regional Market Dynamics

The market for Brilliant Blue FCF colors, including Brilliant Blue G, varies by region:

• North America: This region holds a significant share of the market, with a value share of 39.57% and a projected CAGR of 4.2% between 2022 and 2032[2][5].
• Latin America: The Latin America market accounted for US$ 7.6 million in value and 708 metric tons by volume in 2021[5].
• Asia: The China market is anticipated to register a CAGR of 4.9% during the forecast period, while the Indian market is expected to grow at a CAGR of 6%[5].

Market Projections

Growth Drivers

The growth of the Brilliant Blue FCF colors market, which includes Brilliant Blue G, is driven by several factors:

• Demand for Processed Foods: The increasing demand for processed and commercially available foods that require artificial coloring is a significant driver. Brilliant Blue FCF is widely used to enhance the color of these products[5].
• Social Media Influence: The influence of social media platforms on consumer preferences for aesthetically appealing food and beverages also contributes to market growth[5].

Challenges and Restraints

Despite the growth potential, there are several challenges facing the market:

• Natural Ingredients Awareness: Increasing awareness about natural food ingredients may reduce the demand for synthetic dyes like Brilliant Blue FCF[5].
• Dye Allergies and Regulations: Rising cases of dye allergies and stringent government regulations on the use of food colors are additional restraints[5].

Applications and Uses

Ophthalmology

In ophthalmology, Brilliant Blue G is used specifically for staining the internal limiting membrane during surgical procedures. This application is critical for improving the visualization and safety of these surgeries[4].

Food and Cosmetics

As Brilliant Blue FCF, the dye is used in a variety of food products, dietary supplements, and cosmetics to provide a blue color. It is often combined with tartrazine to produce shades of green[2].

Key Statistics

• Market Size (2022): US$ 53.8 million[2][5].
• Projected Market Valuation (2032): US$ 97.2 million[2][5].
• CAGR (2022-2032): 4.8%[2][5].
• Volume Sales (2021): About 5,000 metric tons[2].

Expert Insights

"Brilliant blue FCF color producers are striving to generate high revenues by partnering up with cereals, cakes, pastries, savory snacks, ice-creams, jellies, and licorice manufacturers. They are also focusing on establishing strategic alliances with regional bakery and candy brands to gain a competitive edge," says a Future Market Insights analyst[5].

Conclusion

Brilliant Blue G, particularly in its ophthalmic application, has demonstrated a strong safety profile and efficacy in clinical trials. The market for Brilliant Blue FCF colors, which includes Brilliant Blue G, is expected to grow steadily driven by the demand for processed foods and the influence of social media. However, the market faces challenges from increasing consumer preference for natural ingredients and regulatory constraints.

Key Takeaways

• Clinical Safety: Brilliant Blue G has a low potential for toxicity and is safe for use in ophthalmologic surgical procedures.
• Market Growth: The global Brilliant Blue FCF colors market is projected to grow at a CAGR of 4.8% from 2022 to 2032.
• Regional Dynamics: North America holds a significant share of the market, while regions like China and India are expected to show higher growth rates.
• Challenges: The market faces restraints from consumer preference for natural ingredients and regulatory issues.

FAQs

What is Brilliant Blue G used for in ophthalmology?

Brilliant Blue G is used in ophthalmology for staining the internal limiting membrane during surgical procedures to improve visualization and safety.

Is Brilliant Blue G safe for use?

Clinical trials have shown that Brilliant Blue G has a relatively safe profile with minimal adverse events and no detectable toxic effects at high concentrations.

What is the projected market size of Brilliant Blue FCF colors by 2032?

The global Brilliant Blue FCF colors market is projected to reach a valuation of US$ 97.2 million by 2032.

What are the main drivers of the Brilliant Blue FCF colors market?

The main drivers include the demand for processed foods and the influence of social media on consumer preferences for aesthetically appealing products.

What are the challenges facing the Brilliant Blue FCF colors market?

Challenges include increasing consumer awareness about natural ingredients, rising cases of dye allergies, and stringent government regulations on the use of synthetic food colors.

Sources

1. Accessdata.fda.gov: 209569Orig1s000 CLINICAL REVIEW(S) - accessdata.fda.gov
2. Future Market Insights: Brilliant Blue FCF Colors Market Size, Share & Trends - 2032
3. Synapse.patsnap.com: Carl-Zeiss-Stiftung - Drug pipelines, Patents, Clinical trials - Synapse
4. Accessdata.fda.gov: 209569Orig1s000 SUMMARY REVIEW - accessdata.fda.gov
5. Globenewswire.com: Brilliant Blue FCF Colors Market to Reach US$ 97.2 Mn, Globally, by 2032 at 4.8% CAGR – Future Market Insights, Inc.