CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 370 enrolled
Drug / intervention
APP13007, 0.05% +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04810962
NCT04810962Phase 3Completed
CompareCT.gov

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

Formosa Pharmaceuticals, Inc.·interventional·Posted Mar 23, 2021·Updated Jul 25, 2023

In Brief

A Phase 3 clinical trial evaluating APP13007, 0.05% and Matching Vehicle Placebo for APP13007, 0.05% for Ocular Inflammation and Pain After Cataract Surgery. Completed, enrolled 370 participants across 31 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOcular Inflammation and Pain After Cataract Surgery
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedMar 23, 2021
Enrollment StartMar 16, 2021
Primary CompletionJul 6, 2022
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 5.3 years ago

Interventions

APP13007, 0.05%drug

APP13007 eye drop, 0.05%

Matching Vehicle Placebo for APP13007, 0.05%drug

Matching vehicle placebo eye drop