OC-01 (Varenicline) Nasal Spray and Dry Eye Signs and Symptoms in Daily Disposable Contact Lens Wearers

Last updated: November 1, 2022
Sponsor: Center for Ophthalmic and Vision Research, LLC
Overall Status: Completed

Phase

4

Condition

Dry Eyes

Eyelid Inflammation

Sjogren's Syndrome

Treatment

N/A

Clinical Study ID

NCT05161208
OP-001
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This study is a single center, prospective, randomized, controlled, double-masked, two-arm investigator-initiated study to investigate the efficacy of OC-01 (varenicline) nasal spray on the signs and symptoms of dry eye disease in daily soft contact lens wearers.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Provide signed written consent prior to study-related procedures.
  2. Be ages 18 to 70 3. Is a symptomatic CL wearer with a CLDEQ-8 score of ≥12 points atbaseline at the end of wear time.
  3. Soft contact lens wearers with self-reported complaints of dryness and/or reducedcontact lens wear time.
  4. Wear soft contact lenses 2 or more days a week for more than 1 month in both eyes.
  5. Currently wears daily soft lenses in both eyes, for a minimum of 2 days/week for 6hours/day over the last month, and is willing to continue to do so during the study.
  6. Have a current contact lens prescription. 8. Best corrected visual acuity of 20/25-2 orbetter in each eye (Can achieve acceptable lens fit as well as visual acuity (VA)correctable to logMAR +0.10 or better in each eye with their habitual contact lens type).
  7. History or current use of artificial tears at least once in the last 30 days.
  8. Be literate and able to complete questionnaires independently. 11. Be able and willingto use the study drug and participate in all study assessments and visits.
  9. Have sufficient hand strength, in the opinion of the Investigator, to be able toindependently administer the study drug.
  10. Have provided written informed consent. 14. If a female is of childbearing potential,they must not plan to get pregnant during the study.

Exclusion

Exclusion Criteria:

  1. Wearing soft CLs on an extended wear basis (i.e. overnight) or is a rigid gaspermeable lens or hybrid lens wearer
  2. Patients with dry eye complaints that the investigator deems are not related to dryeyes will be discontinued at Visit 1.
  3. Using prescription eyedrops for the treatment of dry eye disease (ex. Steroids,Lifitegrast, Cyclosporine)
  4. Clinically significant ocular trauma.
  5. Active or Inactive ocular Herpes simplex or Herpes Zoster infection
  6. Ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis,conjunctivitis) at the discretion of the investigator.
  7. Ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungal infectionor the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids includinghordeolum/stye).
  8. Severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis,staphylococcal blepharitis or seborrheic blepharitis)
  9. Eyelid abnormalities that significantly affect the lid function (e.g., entropion,ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severeptosis).
  10. Ocular surface abnormality that may compromise the corneal integrity (e.g., priorchemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 cornealfluorescein staining, map dot fingerprint dystrophy, or the effect of any otherophthalmic medication that might in the opinion of the investigator compromise theocular surface integrity).
  11. Have a systemic condition or disease not stabilized or judged by the Investigator tobe incompatible with participation in the study or with the lengthier assessmentsrequired by the study (e.g., current systemic infection, uncontrolled autoimmunedisease, uncontrolled immunodeficiency disease, history of myocardial infarction orheart disease, etc.)
  12. Have had nasal or sinus surgery (including history of application of nasal cautery) orsignificant trauma to these areas
  13. Be currently treated with nasal continuous positive airway pressure
  14. Have any untreated nasal infection at Visit 1
  15. Have a vascularized polyp, severely deviated septum, chronic recurrent nosebleeds, orsevere nasal obstruction.
  16. Have current concomitant use of a nicotinic acetylcholine receptor agonist [Nicoderm®,Nicorette®, Nicotrol NS® (nicotine), Tabex®, Desmoxan® (cytisine), and Chantix® (varenicline)] within the previous 30 days of Visit 1 and during the treatment period.
  17. Use of topical presecription ophthalmic medications including cyclosporine,liftegrast, steroids, non-steroidal anti-inflammatory drugs, anti-glaucoma medicationswithin 7 days of screening or during study period.
  18. Prescription and OTC ophthalmic mast cell stabilizers and antihistamines within 21days of screening and throughout study period (systemic permitted.)
  19. Have a known hypersensitivity to any of the procedural agents or study drug components
  20. Have active or uncontrolled, severe at the discretion of the investigator: (a)Systemic allergy, (b) Chronic seasonal allergies at risk of being active during thestudy treatment period, (c) Rhinitis or sinusitis requiring treatment such asantihistamines, decongestants, oral or aerosol steroids at the Screening Visit or beexpected to require treatment during the treatment period of the study
  21. Be currently enrolled in an investigational drug or device study or have used aninvestigational drug or device within 30 days prior to Visit 1 and during thetreatment period.
  22. Be a female who is pregnant, nursing, or planning a pregnancy at Visit 1. Be a womanof 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 barriersuch as a diaphragm or condom; IUD; or surgical sterilization of partner.

Study Design

Total Participants: 75
Study Start date:
December 03, 2021
Estimated Completion Date:
July 25, 2022

Connect with a study center

  • Center for Ophthalmic and Vision Recearch

    New York, New York 10022
    United States

    Site Not Available

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