Clinical Trial to Evaluate the Efficacy and Safety of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease
- Conditions
- Dry Eye Disease
- Interventions
- Drug: Placebo (vehicle)
- Registration Number
- NCT05378945
- Lead Sponsor
- Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 340
- Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to the Screening Visit
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OC-01 Varenicline Tartrate Nasal Spray - Placebo Placebo (vehicle) -
- Primary Outcome Measures
Name Time Method Schirmer's Test Score 28 days Percentage of subjects who achieve ≥10 mm improvement in Schirmer's Test Score from baseline
- Secondary Outcome Measures
Name Time Method Mean change from Baseline in Schirmer's Test Score (STS) 28 days Schirmer's test scores are from 0-35 mm where a higher score is indicative of a better outcome.
Mean change from Baseline in Eye Dryness Score (EDS) 28 days/ 14 days/ 7days Eye dryness score is assessed on a visual analogue scale with scores ranging from 0 to 100 (0=no discomfort; 100=maximal discomfort) and lower scores indicate a better outcome
Trial Locations
- Locations (20)
Henan Eye Hospital
🇨🇳Zhengzhou, Henan, China
The Second Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Beijing Tongren Hospital
🇨🇳Beijing, Beijing, China
The Affiliated Hospital of Guizhou Medical University
🇨🇳Guiyang, Guizhou, China
Beijing Hospital
🇨🇳Beijing, Beijing, China
Zhujiang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Hebei Eye Hospital
🇨🇳Xingtai, Hebei, China
Shijiazhuang People's Hospital
🇨🇳Shijiazhuang, Hebei, China
The First Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, 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, China
Tongji Hospital of Tongji University
🇨🇳Shanghai, Shanghai, China
Tianjin Medical University Eye Hospital
🇨🇳Tianjin, Tianjin, China
The Second Affiliated Hospital Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China