Dry Eye DiseasePhase 1NCT05576415
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of OC-01 in Adult Chinese With Dry Eye Disease
A Phase 1 study testing Varenicline Tartrate Nasal Spray in people with Dry Eye Disease, run by Corxel Pharmaceuticals at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- Varenicline Tartrate Nasal Spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 7 Dec 2022to 27 Apr 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to the Screening Visit
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Dry Eye Disease
- Being tested
- Varenicline Tartrate Nasal Spray
- Keywords
- OC-01 (Varenicline Solution), Dry Eye Disease
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varenicline Tartrate Nasal SprayDrug
Also called OC-01 (varenicline solution) Nasal Spray
Intranasal delivery of OC-01 (varenicline solution) 0.6 mg/mL twice a day (BID) for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| OC-01 | Experimental | Not described Receives: Drug: Varenicline Tartrate Nasal Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Visit 3 [Day 28]: From predose of the last dosing to 120 hours post-dose
Secondary outcomes (2)
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.
Measured: 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.
Measured: From Day 14 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start7 Dec 2022
- Primary completion27 Apr 2023
- Study completion27 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corxel Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Oyster Point Pharma, Inc.
- Responsible party
- Sponsor
- Investigators
- LU, Doctor, Principal investigator, Huashan HospitalZHANG, Doctor, Principal investigator, Huashan HospitalDING, Study director, Corxel Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05576415
- Sponsor's protocol ID
- JX03003
- Status last verified
- Apr 2023
- First submitted
- 27 Sep 2022
- Last updated
- 1 May 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05576415
- Acronym / sponsor ID
- JX03003
- Conditions
- Dry Eye Disease
- Keywords
- OC-01 (Varenicline Solution), Dry Eye Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Corxel PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Oyster Point Pharma, Inc.
- Study start
- 7 Dec 2022 (actual)
- Primary completion
- 27 Apr 2023 (actual)
- Study completion
- 27 Apr 2023 (actual)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OC-01 | Experimental | Drug: Varenicline Tartrate Nasal Spray |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to the Screening Visit
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Varenicline Tartrate Nasal SprayAlso: OC-01 (varenicline solution) Nasal SprayIntranasal delivery of OC-01 (varenicline solution) 0.6 mg/mL twice a day (BID) for 28 days. | Drug | OC-01 |
Primary outcome
Cmax of varenicline after the first dosing at Visit 1 [Day 1] and after the last dosing at Visit 3 [Day 28], respectively.
Time frame: 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.
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.
Tmax of varenicline after the first dosing at Visit 1 [Day 1] and after the last dosing at Visit 3 [Day 28], respectively.
Time frame: 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.
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.
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.
Time frame: 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.
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.
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.
Time frame: 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.
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.
T1/2 of varenicline after the last dosing at Visit 3 [Day 28]
Time frame: Visit 3 [Day 28]: From predose of the last dosing to 120 hours post-dose
To evaluate the T1/2 of varenicline after the last dosing at Visit 3 [Day 28] in adult Chinese subjects with DED.
λz of varenicline after the last dosing at Visit 3 [Day 28]
Time frame: Visit 3 [Day 28]: From predose of the last dosing to 120 hours post-dose
To evaluate the λz of varenicline after the last dosing at Visit 3 [Day 28] in adult Chinese subjects with DED.
2 secondary outcomes
Change from baseline in Schirmer's Test Score (STS) at Visit 1 [Day 1], Visit 2 [Day 14] and Visit 3 [Day 28]
Time frame: From Day 1 to Day 28
Change from baseline in Eye Dryness Score (EDS) at Visit 2 [Day 14] and Visit 3 [Day 28]
Time frame: From Day 14 to Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LU, Doctor principal investigator
Huashan Hospital
ZHANG, Doctor principal investigator
Huashan Hospital
DING study director
Corxel Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Varenicline Tartrate Nasal Spray in people with Dry Eye Disease, run by Corxel Pharmaceuticals at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of varenicline after the first dosing at Visit 1 [Day 1] and after the last dosing at Visit 3 [Day 28], respectively. (time frame: 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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2023.