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

Phase 2

Completed

Interventions: Drug: OC-01 (varenicline) nasal spray 1.2 mg/ml
Drug: Placebo (vehicle) nasal spray

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 mean change from baseline in corneal fluorescein staining in subjects with Stage 1 (corneal epithelial hyperplasia/punctate keratopathy) neurotrophic keratopathy (NK) in one or both eyes.

Detailed Description: Protocol OPP-102 is a Phase 2, multicenter, randomized, controlled, double- masked study designed to evaluate the safety and efficacy of OC-01 (varenicline) nasal spray in subjects with NK. Approximately 100 subjects at least 18 years of age with a physicians' diagnosis of Stage 1 NK as defined by the Mackie Criteria and meeting all other study eligibility criteria will be randomized 1:1 and will receive OC-01 (varenicline)/ nasal spray or placebo nasal spray for 8 weeks three times daily (TID) as follows:

* OC-01 (varenicline) nasal spray, 1.2 mg/mL

* Placebo (vehicle control) nasal spray All doses will be delivered as a 50 microliter (µL) nasal spray.

Recruitment & Eligibility

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.
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.
Be currently receiving autologous serum tears, amniotic membrane, cenegermin, fresh frozen plasma or cord blood derivative tears.
Have severe blepharitis and/or severe meibomian gland disease in the study eye.

Arm && Interventions

Group	Intervention	Description
OC-01 (varenicline) nasal spray, 1.2 mg/mL	OC-01 (varenicline) nasal spray 1.2 mg/ml	OC-01 (varenicline) nasal spray, 1.2 mg/mL
Placebo (vehicle control) nasal spray	Placebo (vehicle) nasal spray	Placebo (vehicle control) nasal spray

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Corneal Fluorescein Staining	8 weeks	Corneal Fluorescein Staining was measured utilizing the Modified Oxford Grading scale. Scores range from a minimum of 0 (no staining) to a maximum of 5. A higher score indicates a worse outcome. The study eye is defined as the eye with the worst staining grade (if both eyes are eligible).

Secondary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Visual Acuity at Week 8	8 weeks	Best Corrected Visual Acuity was assessed based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. ETDRS letters score range from 0 to 100 letters at each assessment. A higher score in ETDRS letters indicates a better outcome. A positive change from Baseline in ETDRS letter score indicates an improvement in visual acuity.

Locations (31): Dothan Alabama
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Dothan, Alabama, United States
Irvine, California
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Irvine, California, United States
Los Angeles California
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Los Angeles, California, United States
Mission Hills California
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Mission Hills, California, United States
Aurora Colorado
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Aurora, Colorado, United States
Littleton, Colorado
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Littleton, Colorado, United States
Longmont, Colorado
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Longmont, Colorado, United States
Danbury, Connecticut
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Danbury, Connecticut, United States
Brandon Florida
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Brandon, Florida, United States
Brandon, Florida
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Brandon, Florida, United States
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Dothan Alabama
🇺🇸Dothan, Alabama, United States