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0.05% CBT-004 for Pinguecula

Phase 2
Recruiting
Research Sponsored by Cloudbreak Therapeutics, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥ 18 years of age.
Pinguecula with a vascularity grade ≥ 3 on a 5-point (0-4) scale.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 month
Awards & highlights

Study Summary

This trial is a study that will last for 4 weeks, with an additional 4 weeks of follow-up observations. It is a multicenter study, meaning it will take place at multiple locations.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects are not explicitly listed here but may include typical reactions associated with eye drops such as irritation, redness, or itching at the site of application.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I have a pinguecula with significant blood vessel growth.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in conjunctival hyperemia grade at Day 28 (Week 4).
Secondary outcome measures
Change from Baseline conjunctival hyperemia digital image grade at Days 7 (Week 1) and 56 (Week 8).

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: 0.075% CBT-004Experimental Treatment1 Intervention
Group II: 0.05% CBT-004Experimental Treatment1 Intervention
Group III: CBT-004Placebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Cloudbreak Therapeutics, LLCLead Sponsor
5 Previous Clinical Trials
946 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age criterion for participation in this study inclusive of individuals who are 70 years or older?

"This clinical investigation is seeking individuals who are at least 18 years old but not yet 80 years of age."

Answered by AI

What is the upper limit on the number of individuals enrolled in this clinical trial?

"Indeed, the details provided on clinicaltrials.gov confirm that patient recruitment is ongoing for this study. The trial was first posted on December 21, 2023 and underwent its latest update on January 25, 2024. This particular trial aims to enroll a total of 75 patients from a single designated site."

Answered by AI

Are there any available slots for patients to participate in this research study?

"Indeed, the information available on clinicaltrials.gov affirms that this trial is actively seeking eligible participants. It was initially posted on December 21st, 2023 and most recently updated on January 25th, 2024. The study aims to enroll a total of 75 patients from one designated site."

Answered by AI

What is the level of safety exhibited by patients receiving treatment with a 0.05% concentration of CBT-004?

"Based on the classification of this trial as Phase 2, our team at Power rates the safety of 0.05% CBT-004 as a 2. This implies that while there is some preliminary data supporting its safety, no evidence has been found regarding its effectiveness yet."

Answered by AI

Which individuals meet the eligibility criteria to enroll in this medical research study?

"- Pinguecula exhibiting a vascularity grade of ≥3 on a scale ranging from 0 to 4."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy Study of CBT-004 in Patients With Vascularized Pinguecula
2023. "Safety and Efficacy Study of CBT-004 in Patients With Vascularized Pinguecula". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04884256.
~50 spots leftby Aug 2025
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