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

NCT04884256 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2025-06-05

No results posted yet for this study

Summary

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.

Conditions

  • Pinguecula

Interventions

DRUG

CBT-004

Dose response study

Sponsors & Collaborators

  • Cloudbreak Therapeutics, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-21
Primary Completion
2025-04-17
Completion
2025-05-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04884256 on ClinicalTrials.gov