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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Drug: Varenicline Tartrate Nasal Spray
* Drug: Placebo (vehicle)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OC-01, Dry Eye Disease