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

NCT04810962 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2023-07-25

Study results available
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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.

Conditions

  • Ocular Inflammation and Pain After Cataract Surgery

Interventions

DRUG

APP13007, 0.05%

APP13007 eye drop, 0.05%

DRUG

Matching Vehicle Placebo for APP13007, 0.05%

Matching vehicle placebo eye drop

Sponsors & Collaborators

  • Formosa Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Chief Medical Officer · AimMax Therapeutics Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-16
Primary Completion
2022-07-06
Completion
2022-07-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04810962 on ClinicalTrials.gov