At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 378 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.
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
In Brief
A Phase 3 clinical trial evaluating APP13007, 0.05% and Matching Vehicle Placebo for APP13007, 0.05% for Ocular Inflammation and Pain. Completed, enrolled 378 participants across 35 sites in 2 countries.
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 1; POD1) after uncomplicated surgery for eligibility for randomization to study treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOcular Inflammation and Pain
CountriesPuerto Rico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
Enrollment StartJan 2021
First PostedFeb 2021
Primary CompletionMar 2022
TodayJul 2026
First PostedFeb 5, 2021
Enrollment StartJan 11, 2021
Primary CompletionMar 17, 2022
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 5.4 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