Clinical Trial to Evaluate the Efficacy and Safety of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease

Dry Eye Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05378945
• Other study ID #: JX03002
• Status: Completed
• Phase: Phase 3
• Start date: July 22, 2022
• Est. completion date: April 4, 2023

Study information

• Verified date: April 2023
• Source: Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: April 4, 2023
• Est. primary completion date: April 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to the Screening Visit

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Beijing Hospital	Beijing	Beijing
China	Beijing Tongren Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	The First Bethune Hospital of Jilin University	Changchun	Jilin
China	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong
China	The Affiliated Hospital of Guizhou Medical University	Guiyang	Guizhou
China	The Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	The Second Hospital of Anhui Medical University	Hefei	Anhui
China	Eye Hospital of Shandong First Medical University	Jinan	Shandong
China	Nanjing First Hospital	Nanjing	Jiangsu
China	Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Tongji Hospital of Tongji University	Shanghai	Shanghai
China	Shijiazhuang People's Hospital	Shijiazhuang	Hebei
China	Tianjin Medical University Eye Hospital	Tianjin	Tianjin
China	Weifang Eye Hospital	Weifang	Shandong
China	Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan	Hubei
China	Wuhan Aier Eye Hospital Hankou Hospital	Wuhan	Hubei
China	Hebei Eye Hospital	Xingtai	Hebei
China	Henan Eye Hospital	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.	Oyster Point Pharma, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean change from Baseline in Total Corneal Fluorescein Staining		28 days
Other	Mean change from Baseline in Inferior Corneal Fluorescein Staining		28 days
Other	Mean change from Baseline in Nasal Corneal Fluorescein Staining		28 days
Other	Mean change from Baseline in Temporal Corneal Fluorescein Staining		28 days
Other	Mean change from Baseline in Central Corneal Fluorescein Staining		28 days
Other	Mean change from Baseline in Superior Corneal Fluorescein Staining		28 days
Primary	Schirmer's Test Score	Percentage of subjects who achieve =10 mm improvement in Schirmer's Test Score from baseline	28 days
Secondary	Mean change from Baseline in Schirmer's Test Score (STS)	Schirmer's test scores are from 0-35 mm where a higher score is indicative of a better outcome.	28 days
Secondary	Mean change from Baseline in Eye Dryness Score (EDS)	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	28 days/ 14 days/ 7days