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

Dry Eye Disease Clinical Trial

— TSUNAMI  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05514041
• Other study ID #: 2022-04
• Status: Recruiting
• Phase: Phase 4
• Start date: August 29, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: August 2022
• Source: Stephenson Eye Associates
• Contact: Dee G Stephenson, MD
• Phone: 941.485.1121
• Email: eyedrdee[@]aol.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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 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 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.

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Varenicline solution
OC-01 nasal spray 0.03 mg
• Placebo nasal spray (OC-01 Vehicle Nasal Spray)
Placebo nasal spray (OC-01 Vehicle Nasal Spray)

Locations

Country	Name	City	State
United States	Stephenson Eye Associates	Venice	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Stephenson Eye Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory analysis of change in Cassini	Clinical interpretation and analysis of change in Cassini surface qualifier image elapsed video	Day 1/Day 28
Other	AEs	Incidence and severity of adverse events	28 days
Primary	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	EDS	Mean change from baseline in symptom score (EDS)	Day 28
Secondary	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
Secondary	Corneal fluorescein staining score	Mean change from baseline in corneal fluorescein staining score	Day 28
Secondary	TBUT	Mean change from baseline in fluorescein tear breakup time (TBUT)	Day 28
Secondary	QoL	Mean change from baseline in QOL questionnaire score	Day 21
Secondary	Tear osmolarity	Mean change from baseline in tear osmolarity score	Day 28
Secondary	VA	Mean change from baseline in visual acuity (logMAR)	Day 28
Secondary	IOP	Mean change from baseline in intraocular pressure	Day 28