Phase 2 Clinical Trial to Evaluate OC-01 Nasal Spray in Subjects With Neurotrophic Keratopathy
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)
1 other identifier
interventional
113
1 country
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2021
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 17, 2021
CompletedFirst Submitted
Initial submission to the registry
June 28, 2021
CompletedFirst Posted
Study publicly available on registry
July 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 27, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2023
CompletedResults Posted
Study results publicly available
May 7, 2024
CompletedMay 7, 2024
March 1, 2024
1.6 years
June 28, 2021
March 8, 2024
April 11, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Mean Change From Baseline in Visual Acuity at Week 8
8 weeks
Study Arms (2)
OC-01 (varenicline) nasal spray, 1.2 mg/mL
ACTIVE COMPARATOROC-01 (varenicline) nasal spray, 1.2 mg/mL
Placebo (vehicle control) nasal spray
PLACEBO COMPARATORPlacebo (vehicle control) nasal spray
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Dothan Alabama
Dothan, Alabama, 36301, United States
Irvine, California
Irvine, California, 92697, United States
Los Angeles California
Los Angeles, California, 90095, United States
Mission Hills California
Mission Hills, California, 91345, United States
Aurora Colorado
Aurora, Colorado, 80045, United States
Littleton, Colorado
Littleton, Colorado, 80120, United States
Longmont, Colorado
Longmont, Colorado, 80503, United States
Danbury, Connecticut
Danbury, Connecticut, 06810, United States
Brandon Florida
Brandon, Florida, 33511, United States
Brandon, Florida
Brandon, Florida, 33511, United States
Jacksonville Florida
Jacksonville, Florida, 32256, United States
Miami Florida
Miami, Florida, 33136, United States
Atlanta, Georgia
Atlanta, Georgia, 30339, United States
Hoffman Estates, Illinois
Hoffman Estates, Illinois, 60169, United States
Urbana Illinois
Urbana, Illinois, 61801, United States
Union Kentucky
Edgewood, Kentucky, 41017, United States
Louisville KY
Louisville, Kentucky, 40206, United States
Bowie, Maryland
Bowie, Maryland, 20716, United States
Boston Massachusetts
Boston, Massachusetts, 02114, United States
Kansas City Missouri
Kansas City, Missouri, 64111, United States
Henderson Nevada
Henderson, Nevada, 89052, United States
Bloomfield, New Jersey
Bloomfield, New Jersey, 07003, United States
Dover New Jersey
Dover, New Jersey, 07801, United States
Babylon New York
Babylon, New York, 11702, United States
New York NY
New York, New York, 10029, United States
York, Pennsylvania
York, Pennsylvania, 17408, United States
Houston Texas
Houston, Texas, 77030, United States
Katy, Texas
Katy, Texas, 77494, United States
San Antonio Texas
San Antonio, Texas, 78229, United States
Lynchburg Virginia
Lynchburg, Virginia, 24502, United States
Seattle Washington
Seattle, Washington, 98119, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Marian Macsai, MD
- Organization
- Oyster Point Pharma Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2021
First Posted
July 12, 2021
Study Start
June 17, 2021
Primary Completion
January 27, 2023
Study Completion
April 28, 2023
Last Updated
May 7, 2024
Results First Posted
May 7, 2024
Record last verified: 2024-03