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Allergan Granted Marketing Authorization by the FDA for

Allergan Granted Marketing Authorization by the FDA for 2025

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The document outlines the clinical trial protocol OCUN-029, sponsored by Allergan, Inc., which aims to evaluate the effectiveness of the TrueTear device in providing acute relief from dry eye symptoms after a 45-day application period. The study is a prospective, single-arm trial involving approximately 60 participants who will use the device daily and undergo assessments in a Controlled Adverse Environment (CAE). The primary measure of effectiveness is the change in Eye Dryness Score (EDS) during CAE exposure at Day 45. The protocol includes detailed procedures for participant selection, device usage, safety monitoring, and statistical analysis.

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