Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of OC-01 in Adult Chinese With Dry Eye Disease

Study Overview
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Brief Summary
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The objective of this study is to evaluate the pharmacokinetics (PK) in adult Chinese subjects with dry eye disease (DED)1 after bilateral nasal spray administration of OC-01 (varenicline solution) Nasal Spray at a concentration of 0.6 mg/mL.

Official Title
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An Open-Label, Multiple-Dose Clinical Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of OC-01 (Varenicline Solution) Nasal Spray in Adult Chinese Subjects With Dry Eye Disease

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Drug: Varenicline Tartrate Nasal Spray


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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


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;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of varenicline after the first dosing at Visit 1 [Day 1] and after the last dosing at Visit 3 [Day 28], respectively. | To evaluate the Cmax of varenicline in adult Chinese with dry eye disease (DED) after the first dosing at Visit 1 [Day 1] and after the last dosing at Visit 3 [Day 28], respectively. | Visit 1 [Day 1]: From predose of the 1st dosing to 12 hours post-dose. Visit 3 [Day 28]: From predose of the last dosing to 120 hours post-dose. | 
| Tmax of varenicline after the first dosing at Visit 1 [Day 1] and after the last dosing at Visit 3 [Day 28], respectively. | To evaluate the Tmax of varenicline in adult Chinese subjects with DED after the first dosing at Visit 1 [Day 1] and after the last dosing at Visit 3 [Day 28], respectively. | Visit 1 [Day 1]: From predose of the 1st dosing to 12 hours post-dose. Visit 3 [Day 28]: From predose of the last dosing to 120 hours post-dose. | 
| AUCtau(Area under the concentration-time curve during a dosing interval) of varenicline after the first dosing at Visit 1 [Day 1] and after the last dosing at Visit 3 [Day 28], respectively. | To evaluate the AUCtau of varenicline in adult Chinese subjects with DED after the first dosing at Visit 1 [Day 1] and after the last dosing at Visit 3 [Day 28], respectively. | Visit 1 [Day 1]: From predose of the 1st dosing to 12 hours post-dose. Visit 3 [Day 28]: From predose of the last dosing to 120 hours post-dose. | 
| AUC0-last(Area under the concentration-time curve from time 0 to the time of the last measured non-zero concentration) of varenicline after the first dosing at Visit 1 [Day 1] and after the last dosing at Visit 3 [Day 28], respectively. | To evaluate the AUC0-last of varenicline in adult Chinese subjects with DED after the first dosing at Visit 1 [Day 1] and after the last dosing at Visit 3 [Day 28], respectively. | Visit 1 [Day 1]: From predose of the 1st dosing to 12 hours post-dose. Visit 3 [Day 28]: From predose of the last dosing to 120 hours post-dose. | 
| T1/2 of varenicline after the last dosing at Visit 3 [Day 28] | To evaluate the T1/2 of varenicline after the last dosing at Visit 3 [Day 28] in adult Chinese subjects with DED. | Visit 3 [Day 28]: From predose of the last dosing to 120 hours post-dose | 
| λz of varenicline after the last dosing at Visit 3 [Day 28] | To evaluate the λz of varenicline after the last dosing at Visit 3 [Day 28] in adult Chinese subjects with DED. | Visit 3 [Day 28]: From predose of the last dosing to 120 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Schirmer's Test Score (STS) at Visit 1 [Day 1], Visit 2 [Day 14] and Visit 3 [Day 28] | To assess the Schirmer's Test Score (STS) using Schirmer's strips in adult Chinese subjects with DED after bilateral nasal spray administration of OC-01 (varenicline solution) Nasal Spray at a concentration of 0.6 mg/mL. For STS, the minimum value is 0.0mm, the maximum value is 35.0mm, the higher scores of change mean a better outcome. | From Day 1 to Day 28 | 
| Change from baseline in Eye Dryness Score (EDS) at Visit 2 [Day 14] and Visit 3 [Day 28] | To assess the Eye Dryness Score (EDS) using a Visual Analog Scale (VAS) in adult Chinese subjects with DED after bilateral nasal spray administration of OC-01 (varenicline solution) Nasal Spray at a concentration of 0.6 mg/mL. For EDS, the minimum value is 0mm, the maximum value is 100mm, the higher scores of change mean a worse outcome. | From Day 14 to Day 28 | 

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