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

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 studyassessments and visits
• Have sufficient hand strength, in the opinion of the Investigator, to be able toindependently administer the study drug
• Have provided verbal and written informed consent
• Have an OSDI score ≥ 13,
• Demonstrate corneal fluorescein staining (CFS) score of 2 or more in at least 1corneal region, or a sum of 4 or more for all corneal regions, based on theNational Eye Institute/Industry Workshop Scale
• Demonstrate abnormal Cassini surface qualifier image at screening visit (at thedetermination of the investigator)

Exclusion Criteria:

• Subjects must not:

1. Have undergone ocular surgery (e.g., cataract, corneal or refractive surgicalprocedure) 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) atthe discretion of the investigator
5. Have ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungalinfection 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, severetrichiasis, 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 theeffect of any other ophthalmic medication that might in the opinion of theinvestigator compromise the ocular surface integrity)
9. Have a systemic condition or disease not stabilized or judged by the Investigatorto be incompatible with participation in the study or with the lengthierassessments required by the study (e.g., current systemic infection, uncontrolledautoimmune disease, uncontrolled immunodeficiency disease, history of myocardialinfarction or heart disease, etc.)
10. Have chronic or recurrent epistaxis, coagulation disorders or other conditionsthat, in the opinion of the Investigator, may lead to clinically significant riskof increased bleeding
11. Have had nasal or sinus surgery (including history of application of nasalcautery) 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, chronicrecurrent 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 thetreatment period.
15. Have undergone mechanical treatment for meibomian gland dysfunction using thermalpulsation/expression (e.g., LipiFlow) or intense pulsed light (e.g., OptiLight)

• Have an 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/orlifitegrast within 6 months prior to the Screening/Baseline Visit and during thetreatment period
17. Use topical ophthalmic corticosteroid therapy within 6 weeks prior to theScreening/Baseline visit and during the treatment period
18. Use ophthalmic artificial tear drops within 2 hours prior to any of the studyvisits; any concurrent use of artificial tears should be continued at samefrequency and with no change in brand during the treatment period
19. Use prescription or OTC topical ophthalmic mast cell stabilizers orantihistamines within 3 days of the Screening/Baseline visit and during thetreatment period (systemic agents permitted)
20. Have a known hypersensitivity to any of the procedural agents or study drugcomponents
21. Be currently enrolled in an investigational drug or device study or have used aninvestigational drug or device within 30 days prior to the Screening/Baselinevisit and during the treatment period.