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Phase III Study to Evaluate the Efficacy and Safety of CBT-001 in Patients with Pterygium

Condition: Conjunctival Hyperemia Reduction and Pterygium Lesion Regression

Phase: Phase III
A previous Phase II study had completed. In that study, a CBT-001 ophthalmic solution was evaluated in two stages. Stage 1 was a single ascending dose study  to evaluate the safety, efficacy, and pharmacokinetics of 0.02%, 0.05% and 0.2% CBT-001. )Stage 2 assessed the efficacy and safety of 0.2% CBT-001, administered three time daily (TID) for 4 weeks with a 5 months follow up. The primary endpoint was reduction of pterygium vascularity and the key secondary endpoint was inhibition of lesion growth. Both endpoints showed positive results. The results of the study can be found on ClinicalTrials.gov. After the completion of the trial, we had a successful EOP2 Meeting with FDA.

The Phase III study was submitted for SPA and FDA accepted the protocol with amendment.

Phase III Study Title: Multicenter, Double-Masked, Randomized, Vehicle-Controlled 12-Month (with a 12-month, Double-Masked Extension) Parallel Comparison of the Safety and Efficacy of 0.1% and 0.2% CBT-001, Dosed Twice-Daily, in Patients with Pterygium.

The objective is to evaluate the safety and efficacy of 0.1% and 0.2% CBT-001 emulsion dosed twice daily for 24 months compared to vehicle in reducing conjunctival hyperemia and preventing pterygium progression in eyes with pterygia.

Primary Efficacy Endpoints are focused on the reduction of conjunctival hyperemia caused by pterygium and inhibition of lesion length progression.

More detailed information about this Phase III study can be found on https://clinicaltrials.gov/study/NCT05456425