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NGF for NCP


Title Assessing the Efficacy of Recombinant Human Nerve Growth Factor (rhNGF) treatment in Patients with Neuropathic Corneal Pain (NCP)
Therapeutic Area Corneal Disorders, Dry Eye
Principal Investigator Pedram Hamrah, MD
Min Age 18 Years
Gender Any
Contact Nancy Gee
617-636-5489
neecresearch@tuftsmedicalcenter.org
More Information Pending

Overview

We will investigate the efficacy of Oxervate treatment in patients with neuropathic corneal pain (NCP). NCP subjects could benefit from its trophic effect on corneal nerves function and its capacity to restore the ocular surface environment. The aim is to investigate the efficacy and tolerability of topical rhNGF cenegermin 0.002% (20mcg/mL) in patients with NCP.

Study Details

Inclusion Criteria

1. Symptoms of neuropathic corneal pain at least 3 months, such as burning, stinging, light sensitivity, discomfort or pain.

2. Best corrected distance visual acuity (Snellen <20/200)

3. Ability to speak and understand the English language sufficiently to understand the study, provide written consent, and allow completion of all study assessments

Exclusion Criteria

1. History of active ocular infection, intra-ocular inflammation, or corneal scar/injury

2. History of any ocular surgery within three months before study Visit 1(day 0)

3. Inability to suspend oral medications for NCP

Study Requirements

Patients will be asked to self-administer the study eye drops (cenegermin) 4 times per day (one drop in both eyes every 3-4 hours) for 4 weeks. Once the patients have finished 4 weeks of using the study eye drops 4 times per day, your study doctor will determine if patients should stop the eye drops or increase the frequency to 6 times per day for an additional 4 weeks. Patients will stay in the study for an additional 8 weeks so your study doctor can monitor your eyes and health for any side effects.