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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: Varenicline Tartrate Nasal Spray; Drug: Placebo (vehicle)

• Study Type: Interventional
• Enrollment (Actual): 340
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • The Second Hospital of Anhui Medical University
  • Beijing
    • Beijing, Beijing, China, 100730
      • Beijing Tongren Hospital
    • Beijing, Beijing, China
      • Peking University Third Hospital
    • Beijing, Beijing, China
      • Beijing Hospital
  • Guangdong
    • Guangzhou, Guangdong, China
      • ZhuJiang Hospital of Southern Medical University
  • Guizhou
    • Guiyang, Guizhou, China
      • The Affiliated Hospital of Guizhou Medical University
  • Hebei
    • Shijiazhuang, Hebei, China
      • Shijiazhuang People's Hospital
    • Xingtai, Hebei, China
      • Hebei Eye Hospital
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • The First Affiliated Hospital of Harbin Medical University
  • Henan
    • Zhengzhou, Henan, China
      • Henan Eye Hospital
  • Hubei
    • Wuhan, Hubei, China
      • Union Hospital Tongji Medical College Huazhong University of Science and Technology
    • Wuhan, Hubei, China
      • Wuhan Aier Eye Hospital Hankou Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Nanjing First Hospital
  • Jilin
    • Changchun, Jilin, China
      • The First Bethune Hospital of Jilin University
  • Shandong
    • Jinan, Shandong, China
      • Eye Hospital of Shandong First Medical University
    • Weifang, Shandong, China
      • Weifang Eye Hospital
  • Shanghai
    • Shanghai, Shanghai, China
      • Tongji Hospital of Tongji University
    • Shanghai, Shanghai, China
      • Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
  • Tianjin
    • Tianjin, Tianjin, China
      • Tianjin Medical University Eye Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • The Second Affiliated Hospital Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo (vehicle); Intranasal delivery of placebo (vehicle) twice a day (BID) for 28 days
Experimental: OC-01	Drug: Varenicline Tartrate Nasal Spray; Intranasal delivery of OC-01 (varenicline solution) 0.6 mg/mL twice a day (BID) for 28 days; Other Names: OC-01 (varenicline solution) Nasal Spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Schirmer's Test Score	Percentage of subjects who achieve ≥10 mm improvement in Schirmer's Test Score from baseline	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Time Frame
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
Mean change from Baseline in Temporal Corneal Fluorescein Staining	28 days
Mean change from Baseline in Central Corneal Fluorescein Staining	28 days
Mean change from Baseline in Superior Corneal Fluorescein Staining	28 days

Collaborators and Investigators

• Sponsor: Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.
• Collaborators: Oyster Point Pharma, Inc.
• Investigators: Study Director: DING, Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.; Principal Investigator: JIE, Doctor, Beijing Tongren Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2022
• Primary Completion (Actual): April 4, 2023
• Study Completion (Actual): April 4, 2023

Study Registration Dates

• First Submitted: May 13, 2022
• First Submitted That Met QC Criteria: May 13, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Dry Eye Disease; OC-01
• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: JX03002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes