Evaluation of the Efficacy and Safety of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease
Multicenter, Randomized, Controlled, Double-Masked, Clinical Trial to Evaluate the Efficacy and Safety of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease (The ONSET-2 Study)
1 other identifier
interventional
758
1 country
22
Brief Summary
The objective of this study is to evaluate the safety and effectiveness of OC-01 Nasal Spray as compared to placebo on signs and symptoms of dry eye disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2019
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 23, 2019
CompletedFirst Submitted
Initial submission to the registry
July 25, 2019
CompletedFirst Posted
Study publicly available on registry
July 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 5, 2021
CompletedResults Posted
Study results publicly available
November 22, 2021
CompletedNovember 22, 2021
August 1, 2021
9 months
July 25, 2019
August 23, 2021
October 22, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Percent of Subjects Who Achieve ≥10 mm Improvement in Schirmer's Test Score From Baseline at Visit 4 (Day 28)
The primary endpoint was the percentage of subjects who achieve ≥10 mm improvement in Schirmer's Test Score from baseline to 28 days in the study eye following treatment with OC-01. Schirmer's test scores from 0-35 mm where a higher score is indicative of a better outcome.
28 Days [Visit 1 (baseline) and Visit 4b (28 days)]
Secondary Outcomes (5)
Mean Change From Baseline in Eye Dryness Score in CAE at Week 4 at 5 Minutes
28 Days [Visit 1 (baseline) and Visit 4a (28 days)]
Mean Change From Baseline in Eye Dryness Score From Baseline to Day 28
28 Days [Visit 1 (baseline) and Visit 4b (28 days)]
Mean Change Form Baseline in Schirmer's Test Score From Baseline to Day 28
28 Days [Visit 1 (baseline) and Visit 4b (28 days)]
Mean Change From Baseline in Eye Dryness Score in the Study Eye at Week 2
14 Days [Visit 1 (baseline) and Visit 3 (14 days)]
Mean Change From Baseline in Eye Dryness Score in the Study Eye at Week 1
7 Days [Visit 1 (baseline) and Visit 2 (7 days)]
Study Arms (3)
OC-01 Low Dose, 0.6 mg/mL
ACTIVE COMPARATOROC-01 (varenicline) nasal spray, 0.6 mg/ML
OC-01 High Dose, 1.2 mg/mL
ACTIVE COMPARATOROC-01 (varenicline) nasal spray, 1.2 mg/ML
Placebo (vehicle) nasal spray
PLACEBO COMPARATORPlacebo (vehicle) nasal spray
Interventions
OC-01 (varenicline) nasal spray
Eligibility Criteria
You may qualify if:
- \- Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to Visit 1
You may not qualify if:
- Have had any intraocular surgery (such as cataract surgery) or extraocular surgery in either eye within three months or refractive surgery (e.g. laser-assisted in-situ keratomileusis, laser epithelial keratomileusis, photorefractive keratectomy or corneal implant) within twelve months of Visit 1.
- Have a history or presence of any ocular disorder or condition in either eye that would, in the opinion of the Investigator, likely interfere with the interpretation of the study results or participant safety such as significant corneal or conjunctival scarring; pterygium or nodular pinguecula; current ocular infection, conjunctivitis, or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; ocular herpetic infection; evidence of keratoconus; etc. Blepharitis not requiring treatment and mild meibomian gland disease that are typically associated with dry eye disease are allowed.
- Have a systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study or with the lengthier assessments required by the study (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction or heart disease, etc.)
- Have a known hypersensitivity to any of the procedural agents or study drug components
- Have any condition or history that, in the opinion of the investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Phoenix
Phoenix, Arizona, 85032, United States
New Port Beach
Newport Beach, California, 92663, United States
Fort Collins
Fort Collins, Colorado, 80528, United States
Waterbury
Waterbury, Connecticut, 06708, United States
Delray Beach
Delray Beach, Florida, 33484, United States
Indianapolis
Indianapolis, Indiana, 46290, United States
Louisville
Louisville, Kentucky, 40206, United States
Raynham
Raynham, Massachusetts, 02767, United States
Las Vegas
Las Vegas, Nevada, 89052, United States
Raleigh
Raleigh, North Carolina, 27603, United States
Shelby
Shelby, North Carolina, 28150, United States
Fargo
Fargo, North Dakota, 58103, United States
Cranberry Township
Cranberry Township, Pennsylvania, 16066, United States
Warwick
Warwick, Rhode Island, 02842, United States
Sioux Falls
Sioux Falls, South Dakota, 57108, United States
Nashville
Nashville, Tennessee, 37210, United States
Austin
Austin, Texas, 78731, United States
Houston
Houston, Texas, 77025, United States
San Antonio
San Antonio, Texas, 78209, United States
San Antonio
San Antonio, Texas, 78229, United States
Layton
Layton, Utah, 84041, United States
Lynchburg
Lynchburg, Virginia, 24502, United States
Related Publications (3)
Hauswirth SG, Kabat AG, Hemphill M, Somaiya K, Hendrix LH, Gibson AA. Safety, adherence and discontinuation in varenicline solution nasal spray clinical trials for dry eye disease. J Comp Eff Res. 2023 Jun;12(6):e220215. doi: 10.57264/cer-2022-0215. Epub 2023 Apr 25.
PMID: 37096956DERIVEDNijm LM, Zhu D, Hemphill M, Blemker GL, Hendrix LH, Kabat AG, Gibson AA. Does Menopausal Status Affect Dry Eye Disease Treatment Outcomes with OC-01 (Varenicline Solution) Nasal Spray? A Post Hoc Analysis of ONSET-1 and ONSET-2 Clinical Trials. Ophthalmol Ther. 2023 Feb;12(1):355-364. doi: 10.1007/s40123-022-00607-7. Epub 2022 Nov 18.
PMID: 36401081DERIVEDWirta D, Vollmer P, Paauw J, Chiu KH, Henry E, Striffler K, Nau J; ONSET-2 Study Group. Efficacy and Safety of OC-01 (Varenicline Solution) Nasal Spray on Signs and Symptoms of Dry Eye Disease: The ONSET-2 Phase 3 Randomized Trial. Ophthalmology. 2022 Apr;129(4):379-387. doi: 10.1016/j.ophtha.2021.11.004. Epub 2021 Nov 10.
PMID: 34767866DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jeffrey Nau
- Organization
- Oyster Point Pharma, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2019
First Posted
July 29, 2019
Study Start
July 23, 2019
Primary Completion
April 10, 2020
Study Completion
February 5, 2021
Last Updated
November 22, 2021
Results First Posted
November 22, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share