Last updated on February 2017

An 8-week Study to Evaluate Safety and Efficacy of Recombinant Human Nerve Growth Factor (rhNGF) Eye Drops Solution Versus Vehicle in Patients With Dry Eye


Brief description of study

The phase II study is a single-center, randomized, double-masked, parallel-arm, vehicle-controlled trial, designed to evaluate the safety and efficacy of Recombinant Human Nerve Growth Factor (rhNGF) eye drops at 20 μg/ml concentration administered six times daily for 8 weeks in patients with dry eye.

Detailed Study Description

The proposed phase II study is a single-center, randomized, double-masked, parallel-arm, vehicle-controlled trial, designed to evaluate the safety and efficacy of Recombinant Human Nerve Growth Factor (rhNGF) eye drops at 20 μg/ml concentration administered six times daily for 8 weeks in patients with dry eye. After confirmation of inclusion and exclusion criteria all eligible patients will be randomized at 2:1 ratio to rhNGF or vehicle control treatment with 8 weeks of study treatments administration with 4 weeks Follow-up.

Clinical Study Identifier: NCT03019627

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Giacomina Massaro Giordano, MD

Penn Dry Eye and Ocular Surface Center,University of Pennsylvania
Philadelphia, PA United States
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