Okyo Pharma Ltd
This study is testing a new investigational study drug called Urcosimod Ophthalmic Solution for the treatment of Neuropathic Corneal Pain (NCP).
This research study is to evaluate the safety of Urcosimod Ophthalmic Solution and its effect on the quality of life and vision in participants with Neuropathic Corneal Pain (NCP). The purpose of this research study will see if urcosimod can safely and effectively relieve the signs and symptoms of NCP, and whether it causes any side effects.
Inclusion Criteria: 1. Aged 18 years of age or older. 2. Able and willing to provide written informed consent prior to any study-related procedures. 3. Presence of symptoms of neuropathic corneal pain for at least 3 months defined as the presence of ocular pain associated or not with ocular symptoms of burning, stinging, light sensitivity or discomfort. 4. In at least one eye: 1. Ocular pain score of 5 or more on 0-10 Visual Analogue Scale (VAS) AND in the same eye 2. In Vivo Confocal Microscopy (IVCM) changes of the subbasal corneal nerve plexus assessed by an Investigator who has rec…
Vehicle solution of the study drug (without active ingredient); preservative-free topical ophthalmic solution supplied in unit-dose ampoules; administered QID for 12-weeks.
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