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

Neurotrophic Keratopathy Clinical Trial

Official title:

A Phase 2, Multicenter, Randomized, Controlled, Double-Masked, Clinical Trial to Evaluate the Efficacy and Safety of OC-01 (Varenicline) Nasal Spray in Subjects With Neurotrophic Keratopathy (the Olympia Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04957758
• Other study ID #: OPP-102
• Status: Completed
• Phase: Phase 2
• Start date: June 17, 2021
• Est. completion date: April 28, 2023

Study information

• Verified date: March 2024
• Source: Oyster Point Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: April 28, 2023
• Est. primary completion date: January 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Be at least 18 years of age at Visit 1.

2. Patients with Stage 1 (corneal epithelial hyperplasia/punctate keratopathy) NK in one or both eyes, as defined by the Mackie Criteria.

3. Evidence of decreased corneal sensitivity (= 4 cm using the Cochet-Bonnet aesthesiometer) in at least 1 corneal quadrant.

4. Schirmer's test without anesthesia =3 mm/ 5 minutes in the affected eye.

5. 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:

1. Have Stage 2 or Stage 3 NK affecting one or both eyes.

2. Have ocular graft versus host disease or Stevens-Johnson syndrome.

3. 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.

4. Be currently receiving autologous serum tears, amniotic membrane, cenegermin, fresh frozen plasma or cord blood derivative tears.

5. Have severe blepharitis and/or severe meibomian gland disease in the study eye.

Related Conditions & MeSH terms

• Neurotrophic Keratopathy

Intervention

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

Locations

Country	Name	City	State
United States	Atlanta, Georgia	Atlanta	Georgia
United States	Aurora Colorado	Aurora	Colorado
United States	Babylon New York	Babylon	New York
United States	Bloomfield, New Jersey	Bloomfield	New Jersey
United States	Boston Massachusetts	Boston	Massachusetts
United States	Bowie, Maryland	Bowie	Maryland
United States	Brandon Florida	Brandon	Florida
United States	Brandon, Florida	Brandon	Florida
United States	Danbury, Connecticut	Danbury	Connecticut
United States	Dothan Alabama	Dothan	Alabama
United States	Dover New Jersey	Dover	New Jersey
United States	Union Kentucky	Edgewood	Kentucky
United States	Henderson Nevada	Henderson	Nevada
United States	Hoffman Estates, Illinois	Hoffman Estates	Illinois
United States	Houston Texas	Houston	Texas
United States	Irvine, California	Irvine	California
United States	Jacksonville Florida	Jacksonville	Florida
United States	Kansas City Missouri	Kansas City	Missouri
United States	Katy, Texas	Katy	Texas
United States	Littleton, Colorado	Littleton	Colorado
United States	Longmont, Colorado	Longmont	Colorado
United States	Los Angeles California	Los Angeles	California
United States	Louisville KY	Louisville	Kentucky
United States	Lynchburg Virginia	Lynchburg	Virginia
United States	Miami Florida	Miami	Florida
United States	Mission Hills California	Mission Hills	California
United States	New York NY	New York	New York
United States	San Antonio Texas	San Antonio	Texas
United States	Seattle Washington	Seattle	Washington
United States	Urbana Illinois	Urbana	Illinois
United States	York, Pennsylvania	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Oyster Point Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in Corneal Fluorescein Staining	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).	8 weeks
Secondary	Mean Change From Baseline in Visual Acuity at Week 8	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.	8 weeks