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drugset / Trial / NCT04810962

Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery Including a Corneal Endothelial Cell Sub-study

NCT04810962 ↗

Phase 3 Completed 370 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; POD1) after uncomplicated surgery for eligibility for randomization to study treatment. The study comprises the Main Study and the Endothelial Cell Sub-study.

Timeline

Start
2021-03-16
Primary completion
2022-07-06
Completion
2022-07-06

Outcome

Met primary endpoint

registry analysis (superiority test); APP13007 0.05% BID vs Matching Vehicle Placebo; p <0.001; Chi-squared NCT04810962 ↗

release “report successful top-line results from CPN-302, the second of the two pivotal Phase 3 clinical studies of APP13007” formosapharma.com ↗

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

Drugs

EvaluationDrugModalityDoseRoute
Subject APP13007 Unknown 0.05 % Topical

Indications

No indication recorded.