The primary objective of this study, in subjects with Neuropathic Corneal Pain, is to evaluate the efficacy and safety of OK-101 0.05% and 0.1% as compared to placebo instilled 4 times/day in subjects with neuropathic corneal pain, as assessed by visual analogue scale (VAS).
Detailed Description: Neuropathic corneal pain (NCP) is a complex disease affecting the somatosensory nervous system characterized by different underlying etiologies and pathogenesis. OK-101 is a lipid conjugated chemerin peptide antagonist of the ChemR23 G-protein coupled receptor which is typically found on immune cells of the eye responsible for the inflammatory response. OK-101 has been shown to produce anti-inflammatory and pain-reducing activities in mouse models of dry eye disease and neuropathic corneal pain; and is designed to combat washout through the inclusion of the lipid 'anchor' contained in the candidate drug molecule to enhance the residence time of OK-101 within the ocular environment. Our preclinical studies have shown that treatment with OK-101 abolishes corneal pain in a murine model of NCP.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
18
Tufts Medical Center
Boston, Massachusetts, United States
Assess ocular pain using 0-10 visual analog scale (VAS)
Visual analog scale questionaire will be used to evaluate the pain on 0-10 scale where 0 is no pain and 10 is worst pain imaginable.
Time frame: 16 Weeks
Ocular Pain Assessment Survey (OPAS) scores
Twenty-seven item questionnaires specifically designed to assess symptoms and quality of life in ocular pain.
Time frame: 16 Weeks
Ocular Surface Disease Index (OSDI©) scores
Twelve-item questionnaire to assess symptoms of ocular irritation consistent with dry eye and their impact on vision-related functioning.
Time frame: 16 Weeks
QoL Improvement assesed by OPAS score
Twenty-seven item questionnaires specifically designed to assess symptoms and quality of life in ocular pain
Time frame: 16 Weeks
Drop comfort Scores
Drop Comfort will be assesed using Scale 0-10, with a value of 0 being most comfortable and 10 being least comfortable.
Time frame: 16 Weeks
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