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 (TSUNAMI)

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: Varenicline solution; Drug: Placebo nasal spray (OC-01 Vehicle Nasal Spray)

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Venice, Florida, United States, 34285
      • Stephenson Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
  • 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)

Exclusion Criteria:

• Subjects must not:

  1. Have undergone ocular surgery (e.g., cataract, corneal or refractive surgical procedure) within 6 months prior to the Screening/Baseline Visit
  2. Have evidence of clinically significant ocular trauma
  3. Have active ocular Herpes simplex or Herpes Zoster infection
  4. Have ocular inflammation (uveitis, iritis, scleritis, episcleritis, conjunctivitis or keratitis, with the exception of keratoconjunctivitis sicca) at the discretion of the investigator
  5. Have ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids. including hordeolum)
  6. Have severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis)
  7. Have eyelid abnormalities that significantly affect the lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis)
  8. 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)
  9. 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.)
  10. 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
  11. Have had nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas
  12. Have any untreated nasal infection at Visit 1
  13. Have a history of vascularized nasal polyp, severely deviated septum, chronic recurrent nosebleeds, or severe nasal obstruction
  14. 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.
  15. 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
  16. Use topical prescription ophthalmic medications including cyclosporine and/or lifitegrast within 6 months prior to the Screening/Baseline Visit and during the treatment period
  17. Use topical ophthalmic corticosteroid therapy within 6 weeks prior to the Screening/Baseline visit and during the treatment period
  18. 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
  19. 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)
  20. Have a known hypersensitivity to any of the procedural agents or study drug components
  21. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OC-01 (varenicline solution) nasal spray 0.03 mg; Subjects 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	Drug: Varenicline solution; OC-01 nasal spray 0.03 mg
Placebo Comparator: Placebo nasal spray (OC-01 Vehicle Nasal Spray); Subjects 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	Drug: Placebo nasal spray (OC-01 Vehicle Nasal Spray); Placebo nasal spray (OC-01 Vehicle Nasal Spray)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in surface qualifier image analysis	Change from baseline in surface qualifier image analysis to pre-administration of varenicline solution nasal spray	Day 28
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.	Day 28
Fluorescein staining score	Mean change from baseline in fluorescein staining score	Day 28
Tear Break-up Time (TBUT)	Mean change from baseline in fluorescein tear breakup time (TBUT)	Day 28
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.	Day 21
Visual Acuity (VA)	Mean change from baseline in visual acuity (logMAR)	Day 28
Intraocular Pressure (IOP)	Mean change from baseline in intraocular pressure	Day 28

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events (AEs)	Incidence and severity of adverse events	28 days

Collaborators and Investigators

• Sponsor: Stephenson Eye Associates

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2022
• Primary Completion (Actual): December 5, 2023
• Study Completion (Actual): December 5, 2023

Study Registration Dates

• First Submitted: August 22, 2022
• First Submitted That Met QC Criteria: August 23, 2022
• First Posted (Actual): August 24, 2022

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: 2022-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No