Safety and Efficacy of CBT-001 Ophthalmic Solution in Patients With Pterygium

Summary

Stage 1: Single Ascending Dose, Safety, Tolerability and Pharmacokinetics (n=24) Stage 2: Multiple Dose, Safety and Efficacy Study with 28-day Dosing and 5 months Followup (n=51)

Timeline

Start

2017-04-15

Primary completion

2018-04-30

Completion

2018-04-30

Outcome

Met primary endpoint

registry analysis (superiority test); Vehicle Multi-dose vs CBT-001 Ophthalmic Solution Multi-dose; p <0.001; Cochran-Mantel-Haenszel NCT03049852 ↗

Drugs

Indications