Dry Eye DiseasePhase 3NCT05378945
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 study testing Varenicline Tartrate Nasal Spray in people with Dry Eye Disease, run by Corxel Pharmaceuticals at 20 sites in China.
Trial summary
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. 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?
- Yes, some participants may receive a placebo
- How many people
- 340 participants
- Where
- 20 sitesChina
- Study dates
- 22 Jul 2022to 4 Apr 2023
- Phase
- Phase 3
- 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
20 sites in 1 country.
20 sites in 1 country
China20 sites
Beijing Tongren Hospital
Beijing, Beijing Municipality, 100730
Beijing Hospital
Beijing, Beijing Municipality
Peking University Third Hospital
Beijing, Beijing Municipality
The First Bethune Hospital of Jilin University
Changchun, Jilin
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
The Second Hospital of Anhui Medical University
Hefei, Anhui
Eye Hospital of Shandong First Medical University
Jinan, Shandong
Nanjing First Hospital
Nanjing, Jiangsu
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality
Shijiazhuang People's Hospital
Shijiazhuang, Hebei
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality
Weifang Eye Hospital
Weifang, Shandong
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei
Wuhan Aier Eye Hospital Hankou Hospital
Wuhan, Hubei
Hebei Eye Hospital
Xingtai, Hebei
Henan Eye Hospital
Zhengzhou, Henan
About this study
Official title: 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.
- Conditions
- Dry Eye Disease
- Being tested
- Varenicline Tartrate Nasal Spray, Placebo (vehicle)
- Keywords
- OC-01, 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
Placebo (vehicle)Drug
Intranasal delivery of placebo (vehicle) twice a day (BID) for 28 days
| Study group | Role | What they receive |
|---|---|---|
| OC-01 | Experimental | Not described Receives: Drug: Varenicline Tartrate Nasal Spray |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo (vehicle) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Schirmer's Test Score
Percentage of subjects who achieve ≥10 mm improvement in Schirmer's Test Score from baseline
Measured: 28 days
Secondary outcomes (2)
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.
Measured: 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
Measured: 28 days/ 14 days/ 7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start22 Jul 2022
- Primary completion4 Apr 2023
- Study completion4 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corxel Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Oyster Point Pharma, Inc.
- Responsible party
- Sponsor
- Investigators
- JIE, Doctor, Principal investigator, Beijing Tongren HospitalDING, Study director, Corxel Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378945
- Sponsor's protocol ID
- JX03002
- Status last verified
- Apr 2023
- First submitted
- 13 May 2022
- Last updated
- 25 Apr 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 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05378945
- Acronym / sponsor ID
- JX03002
- Conditions
- Dry Eye Disease
- Keywords
- OC-01, Dry Eye Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Corxel PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Oyster Point Pharma, Inc.
- Study start
- 22 Jul 2022 (actual)
- Primary completion
- 4 Apr 2023 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 18 May 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 safety and effectiveness of OC-01 (varenicline solution) Nasal Spray as compared to placebo (vehicle) on signs and symptoms of dry eye disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OC-01 | Experimental | Drug: Varenicline Tartrate Nasal Spray |
| Placebo | Placebo comparator | Drug: Placebo (vehicle) |
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 |
| Placebo (vehicle)Intranasal delivery of placebo (vehicle) twice a day (BID) for 28 days | Drug | Placebo |
Primary outcome
Schirmer's Test Score
Time frame: 28 days
Percentage of subjects who achieve ≥10 mm improvement in Schirmer's Test Score from baseline
2 secondary outcomes
Mean change from Baseline in Schirmer's Test Score (STS)
Time frame: 28 days
Mean change from Baseline in Eye Dryness Score (EDS)
Time frame: 28 days/ 14 days/ 7days
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 25 Apr 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.
JIE, Doctor principal investigator
Beijing Tongren Hospital
DING study director
Corxel Pharmaceuticals
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Varenicline Tartrate Nasal Spray in people with Dry Eye Disease, run by Corxel Pharmaceuticals at 20 sites 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 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Schirmer's Test Score (time frame: 28 days). 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 25 Apr 2023.