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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05700422

Enrollment

Registered

2023-01-26

Start date

2023-05-01

Completion date

2023-08-31

Last updated

2024-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye, Sjogren's Syndrome

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.

Interventions

DRUGVarenicline Nasal Spray

OC-01 (varenicline solution) 0.03 mg nasal spray

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
OC-01 (Varenicline Solution) 0.03 mg Nasal Spray Varenicline Nasal Spray: OC-01 (varenicline solution) 0.03 mg nasal spray	39
Total	39

Baseline characteristics

Characteristic	OC-01 (Varenicline Solution) 0.03 mg Nasal Spray
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	18 Participants
Age, Categorical Between 18 and 65 years	21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	2 Participants
Race (NIH/OMB) Black or African American	4 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants
Race (NIH/OMB) White	32 Participants
Region of Enrollment United States	39 participants
Sex: Female, Male Female	39 Participants
Sex: Female, Male Male	0 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 39
other Total, other adverse events	22 / 39
serious Total, serious adverse events	0 / 39

Outcome results

Primary

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.