Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-01-03 @ 10:08 AM
Study NCT ID:
NCT04884256
Status:
COMPLETED
Last Update Posted:
2025-06-05
First Post:
2021-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of CBT-004 in Patients With Vascularized Pinguecula
Sponsor:
Cloudbreak Therapeutics, LLC
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: