NCT04884256

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Cloudbreak Therapeutics, LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	CBT-004	Dose response study

Timeline

• Start date: 2023-12-21
• Primary completion: 2025-04-17
• Completion: 2025-05-30
• First posted: 2021-05-12
• Last updated: 2025-06-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study