Nasal Spray Study in Sjogren's Dry Eye Disease

Phase 4

Completed

Conditions: Sjogren's Syndrome
Dry Eye

Interventions: Drug: Varenicline Nasal Spray

Registration Number: NCT05700422

Lead Sponsor: University of Pennsylvania

Brief Summary: This study will investigate how well OC-01 (varenicline) nasal spray can treat the signs and symptoms of dry eye disease in those Sjogren's Syndrome. Patients at least 18 years old with moderate-to-severe Sjogren's dry eye disease may be eligible for this study. If you are eligible to participate in the study and you decide to join, there will be 3 study visits over approximately 1 month. You will also self-administer the nasal spray at home every day, 2 times a day during this month.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 39

Inclusion Criteria

Provide signed written consent prior to study-related procedures
Be at least 18 years of age at the screening visit
Have diagnosed moderate to severe Sjogrens Syndrome via blood work or biopsy Category 2 staining score for Conjunctiva based on the Van Bjisterveld and Utrect scale and 3 staining score for cornea based on the NEI scale
Have been using Cyclosporine or Lifitegrast 3 months
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
If a female is of childbearing potential, they must: use an acceptable means of birth control (acceptable methods of contraception include: hormonal oral, implantable, injectable, or transdermal contraceptives, mechanical spermicide in conjunction with a barrier such as a diaphragm or condom, IUD, or surgical sterilization of partner), and have a negative urine pregnancy test on Day 1

Exclusion Criteria

Have undergone previous ocular surgery (e.g., intraocular, oculoplastic, corneal or refractive surgical procedure)

Have had thermal pulsation or IPL in prior 3 months
Have used topical ophthalmic corticosteroid therapy in prior 4 weeks
Have had cataract surgery in the last 6 months
Have clinically significant ocular trauma.
Have active ocular Herpes simplex or Herpes Zoster infection
Have ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis) at the discretion of the investigator.
Have ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungal infection or the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids including hordeolum/stye).
Have retinal pathology that can limit visual potential and refractive outcomes in the opinion of the investigator
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 ocular surface abnormality that may compromise the corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, map dot fingerprint 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
Be currently treated with nasal continuous positive airway pressure
Have any untreated nasal infection at Visit 1
Have a vascularized polyp, severely deviated septum, chronic recurrent nosebleeds, or severe nasal obstruction as confirmed by intranasal examination performed at Visit 1.
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 Visit 1 and during the treatment period.
Be a female who is pregnant, nursing, or planning a pregnancy at Visit 1. Be a woman of childbearing potential who is not using an acceptable means of birth control; acceptable methods of contraception include: hormonal oral, implantable, injectable, or transdermal contraceptives; mechanical spermicide in conjunction with a barrier such as a diaphragm or condom; IUD; or surgical sterilization of partner. The risks of OC-01 among pregnant patients are not known.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OC-01 (varenicline solution) 0.03 mg nasal spray	Varenicline Nasal Spray	-

Primary Outcome Measures

Name	Time	Method
Mean Change in Cornea Staining	Baseline to Day 28	The National Eye Institute (NEI) scale is the method that will be used to measure corneal staining using fluorescein strips on a scale of 0-3. The scale is a density-based scoring from 0-3 with 0 indicating no staining and 3 indicating highest density of staining.
Mean Change in Eye Dryness Score as Measured by the Visual Analogue Scale (VAS)	Baseline to Day 28	VAS is a validated, subjective measure for acute and chronic pain. Patients rate eye dryness on a scale of 0-100 where 0 corresponds to "no discomfort" and 100 corresponds to "maximal discomfort."
Mean Change in Conjunctival Staining	Baseline to Day 28	The Van Bijsterveld and Utrecht scale is the method that will be used to measure conjunctival staining while using lissamine green dye. The scale is a from 0-3 with 0 indicating no staining and 3 indicating confluent staining.

Secondary Outcome Measures

Name	Time	Method
Mean Change in Best Corrected Visual Acuity	Baseline to Day 28	LogMAR or Logarithm of the Minimum Angle of Resolution was the method used for measuring best correct visual acuity (BCVA). LogMAR is a scale from -0.2 to 1.6 where the letter size is described in LogMAR units such that LogMAR -0.2 is equivalent to 20/12 (best vision) and LogMAR 1.6 is equivalent to 20/800 (Worse vision). The letter size change in units of 0.1 LogMAR from one row to the next.
Mean Change in Dry Mouth Scale	Baseline to Day 28	VAS is a validated, subjective measure for acute and chronic pain. Patients rate mouth dryness on a scale of 0-100 where 0 corresponds to "no discomfort" and 100 corresponds to "maximal discomfort."
Mean Change in Nose Dryness Scale	Baseline to Day 28	VAS is a validated, subjective measure for acute and chronic pain. Patients rate nose dryness on a scale of 0-100 where 0 corresponds to "no discomfort" and 100 corresponds to "maximal discomfort."