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

Dry Eye Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05576415
• Other study ID #: JX03003
• Status: Completed
• Phase: Phase 1
• Start date: December 7, 2022
• Est. completion date: April 27, 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: April 27, 2023
• Est. primary completion date: April 27, 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.

Locations

Country	Name	City	State
China	Huashan Hospital	Shanghai

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
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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
Primary	?z of varenicline after the last dosing at Visit 3 [Day 28]	To evaluate the ?z 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	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
Secondary	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