Safety and Efficacy Study of CBT-004 in Patients With Vascularized Pinguecula
Status:
Not yet recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
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 BID 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. If both eyes meet the
criterion and have the same severity, the left eye will be the study eye. Patients with
bilateral disease will administer study medication only in the study eye. The fellow eyes in
all study subjects will be untreated.
Randomization:
Patients will be randomized in equal ratio to receive vehicle, 0.01%, and 0.024% CBT-004. The
randomization will be stratified by pinguecula vascularity grade (3 or 4) derived from Visit
1 photo.
Visit schedule:
The study will consist of 5 scheduled visits:
- Screening visit (Day-7) (Visit 1)
- Day 1: baseline and randomization visit (Visit 2)
- Weeks 2: Visits 3
- Week 4: Visit 4
- Week 8: final follow-up and exit visit (Visit 5)