Nasal Spray Study in Sjogren's Dry Eye Disease

A Single-arm Investigator Initiated Study to Evaluate the Efficacy of OC-01 (Varenicline Solution) Nasal Spray on Signs and Symptoms of Dry Eye Disease in Subjects With Sjogren's Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye; Sjogren's Syndrome
• Intervention / Treatment: Drug: Varenicline Nasal Spray

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Scheie Eye Institute at the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Provide signed written consent prior to study-related procedures
• Be at least 22 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in eye dryness score as measured by the Visual Analogue Scale (VAS)	VAS is a validated, subjective measure for acute and chronic pain. Patients rate eye dryness on a scale of 1-10 with higher scores indicating high levels of pain.	Baseline to Day 28
Mean change in cornea staining	The NEI scale is the method that will be used to measure corneal staining using fluorescein strips with a higher score indicating a higher level of staining. It divides the corneal and conjunctival surfaces to help measure fluorescein uptake.	Baseline to Day 28
Mean change in conjunctival staining	The Van Bijsterveld and Utrecht scale is the method that will be used to measure conjunctival staining while using lissamine green dye with higher vaules indicating higher levels of staining.	Baseline to Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in best corrected visual acuity		Baseline to Day 28
Mean change in dry mouth scale	VAS is a validated, subjective measure for acute and chronic pain. Patients rate mouth dryness on a scale of 1-10 with higher scores indicating high levels of pain.	Baseline to Day 28
Incidence and severity of adverse events		Baseline to Day 28
Mean change in nose dryness scale	VAS is a validated, subjective measure for acute and chronic pain. Patients rate nose dryness on a scale of 1-10 with higher scores indicating high levels of pain.	Baseline to Day 28

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Oyster Point Pharma, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: January 14, 2023
• First Submitted That Met QC Criteria: January 25, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 2, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Syndrome; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Sjogren's Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: 851655

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.: Yes