CBT-004 for Pinguecula

Overseen By Van Dinh, MBA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Cloudbreak Therapeutics, LLC

Must not be taking: Topical ophthalmic medications

Disqualifiers: Uncontrolled systemic disease, Active ocular disease, Ocular surgery, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

75 Participants Needed

Trial Summary

Do I need to stop taking my current medications for the trial?

You will need to stop using any topical eye medications in the study eye at least 2 weeks before the trial starts (4 weeks for Restasis® or Xiidra®). Artificial tears are allowed until 7 days before the trial and should not be used during the treatment phase.

Is CBT-004 safe for humans?

There is no specific safety data available for CBT-004 or its variants in the provided research articles. ^{1 2 3 4 5}

What is the purpose of this trial?

STUDY DESIGN: Structure: Multicenter, randomized, double-masked, vehicle-controlled, parallel-group study. Duration of Treatment: 4 weeks of study treatment with 4 weeks follow-up observations. Control: Vehicle for CBT-004 (hereafter referred to as Vehicle). Masking: Subjects, Investigators, Study Monitors and the Independent Image Reading Center are all masked to the study medications. Dosage/Dose regimen: One drop of the assigned study medication will be administered in the study eye TID for 4 weeks. The study eye is defined as the qualified eye (i.e., the eye meeting the inclusion criterion for vascularized pinguecula). If both eyes are qualified, then the eye with the more severe vascularity grade at Visit 1 will be the study eye.

Eligibility Criteria

This trial is for adults over 18 with a pinguecula, which is an eye condition that causes a yellowish bump on the white of the eye. Participants must have noticeable blood vessel growth and experience discomfort from their condition. They need to be able to follow the study's procedures and give written consent.

Inclusion Criteria

I have a score of 2 or more on the eye discomfort questionnaire.

I have a pinguecula with significant blood vessel growth.

I can give written consent and commit to all study assessments for the entire duration of the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one drop of the assigned study medication in the study eye TID for 4 weeks

4 weeks

Regular visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• CBT-004

Trial Overview The trial tests CBT-004, a new treatment for pinguecula. It compares CBT-004 with a placebo (Vehicle) in different groups without anyone knowing who gets what (double-masked). The treatment involves putting one drop into the affected eye three times daily for four weeks.

Participant Groups

Group I: 0.075% CBT-004 Experimental Treatment 1 Intervention

Group II: 0.05% CBT-004 Experimental Treatment 1 Intervention

Group III: CBT-004 Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Cloudbreak Therapeutics, LLC

Lead Sponsor

Trials

6

Recruited

1,000+

Findings from Research

The novel paclitaxel microemulsion demonstrated similar pharmacokinetics and antitumor efficacy compared to the standard paclitaxel injection, while significantly reducing allergic reactions associated with Cremophor EL.

In animal studies, the microemulsion did not cause harmful effects like hemolysis or erythrocyte agglutination, indicating a safer profile for patients compared to the conventional injection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel paclitaxel microemulsion containing a reduced amount of Cremophor EL: pharmacokinetics, biodistribution, and in vivo antitumor efficacy and safety. Wang, Y., Wu, KC., Zhao, BX., et al.[2021]

Radiographic contrast media (RCM) such as bilignost, triombrast, and iodamide-380 activate the complement system in rats, indicating a potential immune response triggered by these substances.

The degree of complement activation varies with the type and dose of RCM, with triombrast showing the highest effect, followed by iodamide and bilignost, suggesting that different RCMs may have varying impacts on immune function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of x-ray contrast substances on the complement system of rats]. Sergeev, PV., Kul'berg, AIa., Shimanovskiĭ, NL., et al.[2015]

Polyethoxylated surfactants, specifically Cremophor-EL and Tween-80, have been shown to activate the complement system in human serum and plasma, which may lead to side effects in patients.

The activation of the complement system by these surfactants is linked to therapeutic side effects like acute hypersensitivity and systemic immunostimulation, suggesting that their use in intravenous nanomedicines could pose immunological risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complement activation by polyethoxylated pharmaceutical surfactants: Cremophor-EL, Tween-80 and Tween-20. Weiszhár, Z., Czúcz, J., Révész, C., et al.[2022]

The study found that the excipient Cremophor® EL (CrEL) in the conventional paclitaxel formulation (Taxol®) causes red blood cell (RBC) lysis and other harmful effects, which could lead to complications for patients, especially those with blood disorders.

In contrast, the nanoparticle albumin-bound paclitaxel (Abraxane®) did not cause these adverse effects on RBCs, highlighting that the choice of excipients can significantly impact the safety and efficacy of cancer treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Taxol(®)-induced phosphatidylserine exposure and microvesicle formation in red blood cells is mediated by its vehicle Cremophor(®) EL. Vader, P., Fens, MH., Sachini, N., et al.[2015]

The CF-PTX formulation, which is free from Cremophor EL, showed significantly higher intracellular uptake of paclitaxel (85.4%) compared to the conventional formulation (19.8%), indicating improved delivery of the drug into cancer cells.

In an in vivo study using mice with Ehrlich ascites carcinoma, CF-PTX reduced tumor volume by 72.5%, outperforming the marketed formulation's 58.6% reduction, and also demonstrated a longer mean residence time and elimination half-life, suggesting enhanced efficacy and sustained action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-cancer, pharmacokinetic and biodistribution studies of cremophor el free alternative paclitaxel formulation. Jain, SK., Utreja, P., Tiwary, AK., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

A novel paclitaxel microemulsion containing a reduced amount of Cremophor EL: pharmacokinetics, biodistribution, and in vivo antitumor efficacy and safety. [2021]

2. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Effect of x-ray contrast substances on the complement system of rats]. [2015]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Complement activation by polyethoxylated pharmaceutical surfactants: Cremophor-EL, Tween-80 and Tween-20. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Taxol(®)-induced phosphatidylserine exposure and microvesicle formation in red blood cells is mediated by its vehicle Cremophor(®) EL. [2015]

5. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Anti-cancer, pharmacokinetic and biodistribution studies of cremophor el free alternative paclitaxel formulation. [2019]