Clinical Trial to Evaluate the Efficacy and Safety of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease
A Phase 3, Multicenter, Randomized, Controlled, Double-Masked Clinical Trial to Evaluate the Efficacy and Safety of OC-01 (Varenicline Solution) Nasal Spray on Signs and Symptoms of Dry Eye Disease in Chinese Population
1 other identifier
interventional
340
1 country
20
Brief Summary
The objective of this study is to evaluate the safety and effectiveness of OC-01 (varenicline solution) Nasal Spray as compared to placebo (vehicle) 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 P50-P75 for phase_3
Started Jul 2022
Shorter than P25 for phase_3
20 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
First Submitted
Initial submission to the registry
May 13, 2022
CompletedFirst Posted
Study publicly available on registry
May 18, 2022
CompletedStudy Start
First participant enrolled
July 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 4, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 4, 2023
CompletedApril 25, 2023
April 1, 2023
9 months
May 13, 2022
April 24, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Schirmer's Test Score
Percentage of subjects who achieve ≥10 mm improvement in Schirmer's Test Score from baseline
28 days
Secondary Outcomes (2)
Mean change from Baseline in Schirmer's Test Score (STS)
28 days
Mean change from Baseline in Eye Dryness Score (EDS)
28 days/ 14 days/ 7days
Other Outcomes (6)
Mean change from Baseline in Total Corneal Fluorescein Staining
28 days
Mean change from Baseline in Inferior Corneal Fluorescein Staining
28 days
Mean change from Baseline in Nasal Corneal Fluorescein Staining
28 days
- +3 more other outcomes
Study Arms (2)
OC-01
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Intranasal delivery of OC-01 (varenicline solution) 0.6 mg/mL twice a day (BID) for 28 days
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 the Screening Visit
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 12 months of the Screening Visit
- 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, acute 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 DED are allowed.
- Have a systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in 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 investigational product 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
- Corxel Pharmaceuticalslead
- Oyster Point Pharma, Inc.collaborator
Study Sites (20)
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Tongren Hospital
Beijing, Beijing Municipality, 100730, China
Beijing Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Shijiazhuang People's Hospital
Shijiazhuang, Hebei, China
Hebei Eye Hospital
Xingtai, Hebei, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Henan Eye Hospital
Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Wuhan Aier Eye Hospital Hankou Hospital
Wuhan, Hubei, China
Nanjing First Hospital
Nanjing, Jiangsu, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
Eye Hospital of Shandong First Medical University
Jinan, Shandong, China
Weifang Eye Hospital
Weifang, Shandong, China
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality, China
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
JIE, Doctor
Beijing Tongren Hospital
- STUDY DIRECTOR
DING
Corxel Pharmaceuticals
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
May 13, 2022
First Posted
May 18, 2022
Study Start
July 22, 2022
Primary Completion
April 4, 2023
Study Completion
April 4, 2023
Last Updated
April 25, 2023
Record last verified: 2023-04