Clinical trial NCT04957758: Phase 2 Clinical Trial to Evaluate OC-01 Nasal Spray in Subjects With Neurotrophic Keratopathy
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neurotrophic Keratopathy
Lead sponsor: Oyster Point Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2021-07-12
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Mean Change From Baseline in Corneal Fluorescein Staining
timeFrame: 8 weeks
Secondary outcomes:
measure: Mean Change From Baseline in Visual Acuity at Week 8
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Dothan Alabama
state: Alabama
city: Irvine
country: United States
facility: Irvine, California
state: California
city: Los Angeles
country: United States
facility: Los Angeles California
state: California
city: Mission Hills
country: United States
facility: Mission Hills California
state: California
city: Aurora
country: United States
facility: Aurora Colorado
state: Colorado
city: Littleton
country: United States
facility: Littleton, Colorado
state: Colorado
city: Longmont
country: United States
facility: Longmont, Colorado
state: Colorado
city: Danbury
country: United States
facility: Danbury, Connecticut
state: Connecticut
city: Brandon
country: United States
facility: Brandon Florida
state: Florida
city: Brandon
country: United States
facility: Brandon, Florida
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Florida
state: Florida
city: Miami
country: United States
facility: Miami Florida
state: Florida
city: Atlanta
country: United States
facility: Atlanta, Georgia
state: Georgia
city: Hoffman Estates
country: United States
facility: Hoffman Estates, Illinois
state: Illinois
city: Urbana
country: United States
facility: Urbana Illinois
state: Illinois
city: Edgewood
country: United States
facility: Union Kentucky
state: Kentucky
city: Louisville
country: United States
facility: Louisville KY
state: Kentucky
city: Bowie
country: United States
facility: Bowie, Maryland
state: Maryland
city: Boston
country: United States
facility: Boston Massachusetts
state: Massachusetts
city: Kansas City
country: United States
facility: Kansas City Missouri
state: Missouri
city: Henderson
country: United States
facility: Henderson Nevada
state: Nevada
city: Bloomfield
country: United States
facility: Bloomfield, New Jersey
state: New Jersey
city: Dover
country: United States
facility: Dover New Jersey
state: New Jersey
city: Babylon
country: United States
facility: Babylon New York
state: New York
city: New York
country: United States
facility: New York NY
state: New York
city: York
country: United States
facility: York, Pennsylvania
state: Pennsylvania
city: Houston
country: United States
facility: Houston Texas
state: Texas
city: Katy
country: United States
facility: Katy, Texas
state: Texas
city: San Antonio
country: United States
facility: San Antonio Texas
state: Texas
city: Lynchburg
country: United States
facility: Lynchburg Virginia
state: Virginia
city: Seattle
country: United States
facility: Seattle Washington
state: Washington
Study officials:
References: