A Phase 2 Multicenter, Randomized, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of CBT-004 Ophthalmic Emulsion in Patients With Vascularized Pinguecula
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.
• Pinguecula with a vascularity grade ≥ 3 on a 5-point (0-4) scale.
• Ocular bothersome questionnaire score ≥ 2 on a 5-point (0-4) scale.
• ≥ 18 years of age.
• Able to provide written informed consent and comply with study assessments for the full duration of the study.