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Dry Eye DiseasePhase 4TSUNAMINCT05514041

Evaluation of Tear Film Quality and Stability in Subjects With Dry Eye Disease Using OC-01 (Varenicline Solution) Nasal Spray 0.03 mg as Compared to Vehicle Control Nasal Spray

A Phase 4 study testing Varenicline solution in people with Dry Eye Disease, run by Stephenson Eye Associates at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A randomized, controlled, double-masked, investigator-initiated trial to evaluate tear film quality and stability in subjects with dry eye disease using OC-01 (varenicline solution) nasal spray 0.03 mg as compared to vehicle control nasal spray. Read more about this study

Who is it for?
Ages 22 years and older
Conditions the study is for
Dry Eye Disease
What is being tested?
Varenicline solution
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteUnited States
Study dates
11 Oct 2022to 5 Dec 2023
Phase
Phase 4
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 22 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must:
  • Provide signed written consent prior to study-related procedures
  • Be at least 22 years of age at the screening visit
  • Be literate and able to complete questionnaires independently
  • Be able and willing to use the study drug and participate in all study assessments and visits
  • Have sufficient hand strength, in the opinion of the Investigator, to be able to independently administer the study drug
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  • Have provided verbal and written informed consent
  • Have an Ocular surface disease index (OSDI) score ≥13,
  • Demonstrate corneal fluorescein staining (CFS) score of 2 or more in at least 1 corneal region, or a sum of 4 or more for all corneal regions, based on the National Eye Institute/Industry Workshop Scale
  • Demonstrate abnormal Cassini surface qualifier image at screening visit (at the determination of the investigator)

Who cannot join

  • Subjects must not:
  • Have undergone ocular surgery (e.g., cataract, corneal or refractive surgical procedure) within 6 months prior to the Screening/Baseline Visit
  • Have evidence of clinically significant ocular trauma
  • Have active ocular Herpes simplex or Herpes Zoster infection
  • Have ocular inflammation (uveitis, iritis, scleritis, episcleritis, conjunctivitis or keratitis, with the exception of keratoconjunctivitis sicca) at the discretion of the investigator
  • Have ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids. including hordeolum)
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  • Have severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis)
  • Have eyelid abnormalities that significantly affect the lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis)
  • Have an ocular surface abnormality that may compromise the corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal dystrophy, or the effect of any other ophthalmic medication that might in the opinion of the investigator compromise the ocular surface integrity)
  • Have a systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study or with the lengthier assessments required by the study (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction or heart disease, etc.)
  • Have chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the Investigator, may lead to clinically significant risk of increased bleeding
  • Have had nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas
  • Have any untreated nasal infection at Visit 1
  • Have a history of vascularized nasal polyp, severely deviated septum, chronic recurrent nosebleeds, or severe nasal obstruction
  • Have current concomitant use of a nicotinic acetylcholine receptor agonist [Nicoderm®, Nicorette®, Nicotrol NS® (nicotine), Tabex®, Desmoxan® (cytisine), and Chantix® (varenicline)] within the previous 30 days of Visit 1 and during the treatment period.
  • Have undergone mechanical treatment for meibomian gland dysfunction using thermal pulsation/expression (e.g., LipiFlow) or intense pulsed light (e.g., OptiLight) therapy within 6 months prior to the Screening/Baseline Visit
  • Use topical prescription ophthalmic medications including cyclosporine and/or lifitegrast within 6 months prior to the Screening/Baseline Visit and during the treatment period
  • Use topical ophthalmic corticosteroid therapy within 6 weeks prior to the Screening/Baseline visit and during the treatment period
  • Use ophthalmic artificial tear drops within 2 hours prior to any of the study visits; any concurrent use of artificial tears should be continued at same frequency and with no change in brand during the treatment period
  • Use prescription or Over-the-counter (OTC) topical ophthalmic mast cell stabilizers or antihistamines within 3 days of the Screening/Baseline visit and during the treatment period (systemic agents permitted)
  • Have a known hypersensitivity to any of the procedural agents or study drug components
  • Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to the Screening/Baseline visit and during the treatment period.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stephenson Eye Associates

    Venice, Florida, 34285

Other trials in United States

About this study

Official title: A Randomized, Controlled, Double-masked, Investigator-initiated Trial to Evaluate Tear Film Quality and Stability in Subjects With Dry Eye Disease Using OC-01 (Varenicline Solution) Nasal Spray 0.03 mg as Compared to Vehicle Control Nasal Spray

A randomized, controlled, double-masked, investigator-initiated trial to evaluate tear film quality and stability in subjects with dry eye disease using OC-01 (varenicline solution) nasal spray 0.03 mg as compared to vehicle control nasal spray.

Read the detailed description

A randomized, controlled, double-masked, investigator-initiated trial to evaluate tear film quality and stability in subjects with dry eye disease using OC-01 (varenicline solution) nasal spray 0.03 mg as compared to vehicle control nasal spray.

Conditions
Dry Eye Disease
Being tested
Varenicline solution, Placebo nasal spray (OC-01 Vehicle Nasal Spray)
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 solutionDrug

    OC-01 nasal spray 0.03 mg

  • Placebo nasal spray (OC-01 Vehicle Nasal Spray)Drug

    Placebo nasal spray (OC-01 Vehicle Nasal Spray)

Study groups in NCT05514041
Study groupRoleWhat they receive
OC-01 (varenicline solution) nasal spray 0.03 mgExperimentalSubjects will be randomized 1:1 to be treated with the agent delivered as a 0.05 mL intranasal spray in each nostril at the following formulations
Receives: Drug: Varenicline solution
Placebo nasal spray (OC-01 Vehicle Nasal Spray)Placebo comparatorSubjects will be randomized 1:1 to be treated with the agent delivered as a 0.05 mL intranasal spray in each nostril at the following formulations
Receives: Drug: Placebo nasal spray (OC-01 Vehicle Nasal Spray)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Surface qualifier image change

    Change from baseline in Cassini surface qualifier image analysis to post-administration of OC-01 (varenicline solution) nasal spray (@15 minutes) on Day 1

    Measured: Day 1

Secondary outcomes (7)

  1. Eye Dryness Score (EDS)

    Mean change from baseline in symptom score (EDS) The questionnaire used a 0-100 Visual Analog Scale (VAS), with 0 indicating no discomfort and 100 indicating maximal discomfort.

    Measured: Day 28

  2. Change from baseline in surface qualifier image analysis

    Change from baseline in surface qualifier image analysis to pre-administration of varenicline solution nasal spray

    Measured: Day 28

  3. Fluorescein staining score

    Mean change from baseline in fluorescein staining score

    Measured: Day 28

  4. Tear Break-up Time (TBUT)

    Mean change from baseline in fluorescein tear breakup time (TBUT)

    Measured: Day 28

  5. Dry Eye-Related Quality of Life Score (DEQS) questionnaire

    Mean change in the Dry Eye-Related Quality of Life Score (DEQS) from baseline.

    The questionnaire included 15 questions - 6 about bothersome ocular symptoms and 9 on the impact of DED on daily life. A quality-of-life score ranging from 0 (no disability) to 100 (maximum disability) was calculated.

    Measured: Day 21

  6. Visual Acuity (VA)

    Mean change from baseline in visual acuity (logMAR)

    Measured: Day 28

  7. Intraocular Pressure (IOP)

    Mean change from baseline in intraocular pressure

    Measured: Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2022
  2. Study start11 Oct 2022
  3. Primary completion5 Dec 2023
  4. Study completion5 Dec 2023

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05514041
Sponsor's protocol ID
2022-04
Acronym
TSUNAMI
Status last verified
Apr 2026
First submitted
22 Aug 2022
Last updated
5 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Stephenson PD, Matossian C. The Effect of Varenicline Nasal Spray on the Signs and Symptoms of Dry Eye Disease and Tear Film Stability: A Randomized Controlled Trial. Clin Ophthalmol. 2026 Sep 6;20:610688. doi: 10.2147/OPTH.S610688. eCollection 2026.

    PubMed 42724843

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Varenicline solution in people with Dry Eye Disease, run by Stephenson Eye Associates at 1 site in United States.

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 10 inclusion and 22 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 5 May 2026. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Surface qualifier image change (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05514041, which also lists 1 linked publication.

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 5 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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