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

Stephenson Eye Associates1 site in 1 country60 target enrollmentAugust 29, 2022

ConditionsDry Eye Disease

InterventionsVarenicline solution Placebo nasal spray (OC-01 Vehicle Nasal Spray)

DrugsVarenicline solution Placebo nasal spray (OC-01 Vehicle Nasal Spray)

Overview

Phase: Phase 4
Intervention: Varenicline solution
Conditions: Dry Eye Disease
Sponsor: Stephenson Eye Associates
Enrollment: 60
Locations: 1
Primary Endpoint: Surface qualifier image change
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

August 29, 2022

End Date

September 1, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Stephenson Eye Associates

Responsible Party

Sponsor

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:
•Have undergone ocular surgery (e.g., cataract, corneal or refractive surgical procedure) within 6 months prior to the Screening/Baseline Visit
•Have evidence of clinically significant ocular trauma
•Have active ocular Herpes simplex or Herpes Zoster infection
•Have ocular inflammation (uveitis, iritis, scleritis, episcleritis, conjunctivitis or keratitis, with the exception of keratoconjunctivitis sicca) at the discretion of the investigator
•Have ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids. including hordeolum)
•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 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)
•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.)

Arms & Interventions

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

Intervention: Varenicline solution

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

Intervention: Placebo nasal spray (OC-01 Vehicle Nasal Spray)

Outcomes

Primary Outcomes

Surface qualifier image change

Time Frame: Day 1

Change from baseline in Cassini surface qualifier image analysis to post-administration of OC-01 (varenicline solution) nasal spray (@15 minutes) on Day 1