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

Ocular Inflammation and Pain After Cataract Surgery Clinical Trial

Official title: A Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of APP13007 for the Treatment of Inflammation and Pain After Cataract Surgery, Including a Corneal Endothelial Cell Sub-study

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract
• Inflammation
• Ocular Inflammation and Pain After Cataract Surgery

• NCT number: NCT04810962
• Study type: Interventional
• Source: Formosa Pharmaceuticals, Inc.
• Status: Completed
• Phase: Phase 3
• Start date: March 16, 2021
• Completion date: July 6, 2022