Clinical Trial to Evaluate the Efficacy and Safety of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease
NCT ID: NCT05378945
Last Updated: 2023-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
340 participants
INTERVENTIONAL
2022-07-22
2023-04-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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OC-01
Varenicline Tartrate Nasal Spray
Intranasal delivery of OC-01 (varenicline solution) 0.6 mg/mL twice a day (BID) for 28 days
Placebo
Placebo (vehicle)
Intranasal delivery of placebo (vehicle) twice a day (BID) for 28 days
Interventions
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Varenicline Tartrate Nasal Spray
Intranasal delivery of OC-01 (varenicline solution) 0.6 mg/mL twice a day (BID) for 28 days
Placebo (vehicle)
Intranasal delivery of placebo (vehicle) twice a day (BID) for 28 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Oyster Point Pharma, Inc.
INDUSTRY
Corxel Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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JIE, Doctor
Role: PRINCIPAL_INVESTIGATOR
Beijing Tongren Hospital
DING
Role: STUDY_DIRECTOR
Corxel Pharmaceuticals
Locations
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The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Tongren Hospital
Beijing, Beijing Municipality, 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
Countries
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Other Identifiers
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JX03002
Identifier Type: -
Identifier Source: org_study_id
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