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Completed Phase 2 Interventional

Safety and Efficacy Study of CBT-004 in Patients With Vascularized Pinguecula

ClinicalTrials.gov ID: NCT04884256

Public ClinicalTrials.gov record NCT04884256. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 5:25 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 2 Multicenter, Randomized, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of CBT-004 Ophthalmic Emulsion in Patients With Vascularized Pinguecula

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04884256
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Cloudbreak Therapeutics, LLC
Industry
Enrollment
88 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 20, 2023
Primary completion
Apr 16, 2025
Completion
May 29, 2025
Last update posted
Jun 4, 2025

2023 – 2025

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Global Research Management Glendale California 91204

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04884256, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 4, 2025 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04884256 live on ClinicalTrials.gov.

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