The objective of this study is to compare the safety and efficacy of RGN-259 to placebo for the treatment of Neurotrophic Keratopathy (NK)
Be male or female of any race, at least 18 years of age;
Have provided written informed consent;
Be able and willing to follow instructions, including participation in all study assessments and visits;
At the time of Visit 1, have documentation or observation of a Persistent Epithelial Defect (PED) in one or both eyes, defined as a corneal epithelial defect that has not resolved after 1 week of conventional treatment using non-preserved ocular lubricants, non-preserved topical ophthalmic antibiotics, oral doxycycline, patching, amniotic membrane, serum tears, and/or therapeutic contact lenses;
Have any condition that, in the opinion of the Investigator, would interfere with the subject's ability to complete the study, would interfere with the interpretation of safety or efficacy, or would present an undue risk to the subject.
Have any clinically significant slit-lamp findings in the study eye that in the opinion of the Investigator may interfere with the study parameters;
Clinically significant active blepharitis, meibomian gland dysfunction (MGD), or lid margin inflammation, or active ocular allergy in study eye that requires treatment that in the opinion of the investigator may interfere with the study parameters;
Have a Unanesthetized Schirmer's test score of ≤3 mm at Visit 1;
Parallel
RGN-259
DrugA preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into study eye(s), five times per day for 28 days
Placebo
DrugIt is composed of the same excipients as RGN-259 but does not contain Tβ4. Direct instillation into study eye(s), five times per day for 28 days
Percentage of subjects achieving complete healing of PED at Day 29
Percentage of subjects achieving complete healing of the Persistent Epithelial Defect (PED) at Day 29 determined by corneal fluorescein staining as measured by the Central Reading Center.
Percentage of subjects achieving complete healing of PED at Day 29
Percentage of subjects achieving complete healing of the PED determined by corneal fluorescein staining as measured by the Investigator.
Percentage change from baseline of lesion size
Percentage change from baseline of lesion size determined by corneal fluorescein staining (measurements of greatest dimension of fluorescein staining)
NK stage by Mackie classification
NK stage graded according to the Mackie classification (Stage I, II, III. Higher scores mean a better or worse outcome)
Visual Acuity determined by ETDRS
Visual Acuity determined by Early Treatment of Diabetic Retinopathy Study (ETDRS)
Frequency and severity of AEs
Frequency and severity of AEs as reported according to the NCI CTCAE version 5.0
Number of participants with abnormal vital signs
Blood pressure, heart rate, respiratory rate, oxygen saturation, and body temperature will be measured and assessed its clinical abnormality.
Intraocular Pressure (Unit: mmHg)
Dilated fundoscopy (Vitreous, Retina, Macula, Choroid, Optic Nerve)
The fundoscopy exam will be performed and clinical abnormality of vitreous, retina, Macula, Choroid and Optic Nerve will be described.
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