Phase 2 Clinical Trial to Evaluate OC-01 Nasal Spray in Subjects With Neurotrophic Keratopathy

About

Brief Summary

The objective of this study is to evaluate the safety and effectiveness of OC-01 (varenicline) nasal spray as compared to placebo nasal spray for complete resolution of corneal staining (0 mm lesion and no residual staining) in subjects with Stage 1 (corneal epithelial hyperplasia/punctate keratopathy) neurotrophic keratopathy (NK) in one or both eyes.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 2

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

N/A

Inclusion Criteria:

Be at least 18 years of age at Visit 1.
Patients with Stage 1 (corneal epithelial hyperplasia/punctate keratopathy) NK in one or both eyes, as defined by the Mackie Criteria.
Evidence of decreased corneal sensitivity (≤ 4 cm using the Cochet-Bonnet aesthesiometer) in at least 1 corneal quadrant.
Schirmer's test without anesthesia >3 mm/ 5 minutes in the affected eye with a cotton swab nasal stimulation Schirmer's Test score at least 7 mm greater in the same eye
Have provided verbal and written informed consent.
If a female is of childbearing potential, they must: use an acceptable means of birth control (acceptable methods of contraception include hormonal - oral, implantable, injectable, or transdermal contraceptives, mechanical - spermicide in conjunction with a barrier such as a diaphragm or condom, IUD, or surgical sterilization of partner), and have a negative urine pregnancy test on Day 1.

Exclusion Criteria:

Have Stage 2 or Stage 3 NK affecting one or both eyes.
Have ocular graft versus host disease or Stevens-Johnson syndrome.
Have any active ocular infection (COVID-19 conjunctivitis, bacterial, viral, fungal, or protozoal) or active ocular inflammation not related to NK in the affected eye.
Have any other ocular disease requiring topical ocular treatment in the affected eye during the study treatment period. No topical ocular treatments, other than preservative free artificial tears can be utilized.
Have used Restasis® or Xiidra® Cequa and steroids in the past 30 days prior to Visit 1.
Have severe blepharitis and/or severe meibomian gland disease in the study eye.

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