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

NCT ID: NCT05514041

Last Updated: 2022-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-29
• Study Completion Date: 2023-09-01

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Varenicline solution

Intervention Type: DRUG

OC-01 nasal spray 0.03 mg

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

Group Type: PLACEBO_COMPARATOR

Placebo nasal spray (OC-01 Vehicle Nasal Spray)

Intervention Type: DRUG

Placebo nasal spray (OC-01 Vehicle Nasal Spray)

Interventions

Varenicline solution

OC-01 nasal spray 0.03 mg

Intervention Type: DRUG

Placebo nasal spray (OC-01 Vehicle Nasal Spray)

Placebo nasal spray (OC-01 Vehicle Nasal Spray)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stephenson Eye Associates

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Stephenson Eye Associates

Venice, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Dee G Stephenson, MD

Role: CONTACT

eyedrdee@aol.com

941.485.1121

Facility Contacts

Dee G Stephenson, MD

Role: primary

eyedrdee@aol.com

941-485-1121

Other Identifiers

2022-04

Identifier Type: -

Identifier Source: org_study_id