Status and phase
Conditions
Treatments
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
75 participants in 3 patient groups, including a placebo group
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Central trial contact
Bing Leng, MD; Van Dinh, MBA
Data sourced from clinicaltrials.gov
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