drugset
drugset / Trial / NCT04739709

Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery

NCT04739709 ↗

Phase 3 Completed 378 enrolled Formosa Pharmaceuticals, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This Phase 3 study will evaluate APP13007 in comparison to the matching vehicle placebo in a randomized, parallel-group, double-masked fashion. The subjects will have undergone routine cataract surgery on Day 0 of the study and will be assessed the next day (Post-operative Day 1; POD1) after uncomplicated surgery for eligibility for randomization to study treatment.

Timeline

Start
2021-01-11
Primary completion
2022-03-17
Completion
2022-03-17

Outcome

Met primary endpoint

registry analysis (superiority test); APP13007 0.05% BID vs Matching Vehicle Placebo; p <0.001; Chi-squared NCT04739709 ↗

release “report successful top-line results from CPN-301, the first of two pivotal Phase 3 clinical studies of APP13007” formosapharma.com ↗

release “Treatment with an APP13007 eyedrop twice daily for 14 days met the two primary endpoints by producing rapid and sustained clearance of ocular inflammation” formosapharma.com ↗

release “CPN-301 and CPN-302 successfully achieved the endpoints of rapid and sustained clearance of ocular inflammation and cure of ocular pain” formosapharma.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject APP13007 Unknown 0.05 % Other

Indications

No indication recorded.