Clinical trial NCT05378945: Clinical Trial to Evaluate the Efficacy and Safety of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Disease
Keywords: OC-01
Dry Eye Disease
Lead sponsor: Corxel Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Oyster Point Pharma, Inc.
First posted: 2022-05-18
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Schirmer's Test Score
timeFrame: 28 days
Secondary outcomes:
measure: Mean change from Baseline in Schirmer's Test Score (STS)
timeFrame: 28 days
measure: Mean change from Baseline in Eye Dryness Score (EDS)
timeFrame: 28 days/ 14 days/ 7days
Other outcomes:
measure: Mean change from Baseline in Total Corneal Fluorescein Staining
timeFrame: 28 days
measure: Mean change from Baseline in Inferior Corneal Fluorescein Staining
timeFrame: 28 days
measure: Mean change from Baseline in Nasal Corneal Fluorescein Staining
timeFrame: 28 days
measure: Mean change from Baseline in Temporal Corneal Fluorescein Staining
timeFrame: 28 days
measure: Mean change from Baseline in Central Corneal Fluorescein Staining
timeFrame: 28 days
measure: Mean change from Baseline in Superior Corneal Fluorescein Staining
timeFrame: 28 days
Locations:
city: Hefei
country: China
facility: The Second Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Beijing Tongren Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
city: Guiyang
country: China
facility: The Affiliated Hospital of Guizhou Medical University
state: Guizhou
city: Shijiazhuang
country: China
facility: Shijiazhuang People's Hospital
state: Hebei
city: Xingtai
country: China
facility: Hebei Eye Hospital
state: Hebei
city: Harbin
country: China
facility: The First Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Eye Hospital
state: Henan
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Wuhan Aier Eye Hospital Hankou Hospital
state: Hubei
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
state: Jilin
city: Jinan
country: China
facility: Eye Hospital of Shandong First Medical University
state: Shandong
city: Weifang
country: China
facility: Weifang Eye Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Tongji Hospital of Tongji University
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Medical University Eye Hospital
state: Tianjin
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Beijing Tongren Hospital
name: JIE, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Corxel Pharmaceuticals
name: DING
role: STUDY_DIRECTOR
References: