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

NCT ID: NCT04957758

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-17
• Study Completion Date: 2023-04-28

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.

Conditions

Neurotrophic Keratopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

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

Group Type: ACTIVE_COMPARATOR

OC-01 (varenicline) nasal spray 1.2 mg/ml

Intervention Type: DRUG

OC-01

Placebo (vehicle control) nasal spray

Placebo (vehicle control) nasal spray

Group Type: PLACEBO_COMPARATOR

Placebo (vehicle) nasal spray

Intervention Type: DRUG

Placebo (vehicle)

Interventions

OC-01 (varenicline) nasal spray 1.2 mg/ml

OC-01

Intervention Type: DRUG

Placebo (vehicle) nasal spray

Placebo (vehicle)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oyster Point Pharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dothan Alabama

Dothan, Alabama, United States

Irvine, California

Irvine, California, United States

Los Angeles California

Los Angeles, California, United States

Mission Hills California

Mission Hills, California, United States

Aurora Colorado

Aurora, Colorado, United States

Littleton, Colorado

Littleton, Colorado, United States

Longmont, Colorado

Longmont, Colorado, United States

Danbury, Connecticut

Danbury, Connecticut, United States

Brandon Florida

Brandon, Florida, United States

Brandon, Florida

Brandon, Florida, United States

Jacksonville Florida

Jacksonville, Florida, United States

Miami Florida

Miami, Florida, United States

Atlanta, Georgia

Atlanta, Georgia, United States

Hoffman Estates, Illinois

Hoffman Estates, Illinois, United States

Urbana Illinois

Urbana, Illinois, United States

Union Kentucky

Edgewood, Kentucky, United States

Louisville KY

Louisville, Kentucky, United States

Bowie, Maryland

Bowie, Maryland, United States

Boston Massachusetts

Boston, Massachusetts, United States

Kansas City Missouri

Kansas City, Missouri, United States

Henderson Nevada

Henderson, Nevada, United States

Bloomfield, New Jersey

Bloomfield, New Jersey, United States

Dover New Jersey

Dover, New Jersey, United States

Babylon New York

Babylon, New York, United States

New York NY

New York, New York, United States

York, Pennsylvania

York, Pennsylvania, United States

Houston Texas

Houston, Texas, United States

Katy, Texas

Katy, Texas, United States

San Antonio Texas

San Antonio, Texas, United States

Lynchburg Virginia

Lynchburg, Virginia, United States

Seattle Washington

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

OPP-102

Identifier Type: -

Identifier Source: org_study_id