Nasal Spray Study in Sjogren's Dry Eye Disease

NCT05700422 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 851655
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Sjogren's Syndrome; Dry Eye

Outcome Measures

Primary Outcomes (3)

• Mean Change in Cornea Staining

  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.

  Baseline to Day 28

• 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 0-100 where 0 corresponds to "no discomfort" and 100 corresponds to "maximal discomfort."

  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. The scale is a from 0-3 with 0 indicating no staining and 3 indicating confluent staining.

  Baseline to Day 28

Secondary Outcomes (3)

• Mean Change in Best Corrected Visual Acuity

  Baseline to Day 28

• Mean Change in Dry Mouth Scale

  Baseline to Day 28

• Mean Change in Nose Dryness Scale

  Baseline to Day 28

Study Arms (1)

OC-01 (varenicline solution) 0.03 mg nasal spray

EXPERIMENTAL

Drug: Varenicline Nasal Spray

Interventions

Varenicline Nasal Spray DRUG

OC-01 (varenicline solution) 0.03 mg nasal spray

OC-01 (varenicline solution) 0.03 mg nasal spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Oyster Point Pharma, Inc.: collaborator

Study Sites (1)

Scheie Eye Institute at the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Gupta AS, Linaburg TJ, Iacobucci E, Augello PA, Qin VL, Ying GS, Bunya VY, Massaro M. Varenicline Solution Nasal Spray for the Treatment of Dry Eye Disease in Sjogren's Disease: A Pilot Study. Clin Ophthalmol. 2025 Mar 27;19:1073-1084. doi: 10.2147/OPTH.S512364. eCollection 2025.

  PMID: 40166690 DERIVED

MeSH Terms

Conditions

Sjogren's Syndrome; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Ophthalmology Clinical Research
• Organization: Scheie Eye Institute

ophth.clinicalresearch@pennmedicine.upenn.edu

215-662-8038

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician, Co-Director, Penn Dry Eye & Ocular Surface Center, and Professor of Clinical Ophthalmology

Study Record Dates

• First Submitted: January 14, 2023
• First Posted: January 26, 2023
• Study Start: May 1, 2023
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: November 5, 2024
• Results First Posted: November 5, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)