Investigator Initiated Study to Assess the Efficacy of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease Following Laser-assisted in Situ Keratomileusis (LASIK)

Completed · Phase 3 · Has a placebo group

Conditions studied: Dry Eye Disease

In brief

Evaluate the safety and effectiveness of OC-01 (varenicline) nasal spray for amelioration of signs and symptoms of dry eye disease in subjects following laser-assisted in situ keratomileusis (LASIK).

Key facts

Study ID

NCT05082974

Run by

Vance Thompson Vision ND

People needed

40

Starts

2021-10-20

Expected to finish

2022-08-03

Last updated by the study team

2023-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Be willing and able to sign the informed consent form (ICF)
• Be at least 18 years of age at the screening visit
• Be undergoing LASIK treatment in one or both eyes
• Be myopic between -1.00D to -7.00D MRSE (manifest refraction spherical equivalent) in study eye (right eye) with ≤2D between eyes or subjects undergoing monovision treatment with study eye (distance eye) meeting the diopter requirement of myopia
• 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 baseline

You may not qualify if…

• Subjects must not:
• Have a break in the integrity of the corneal epithelium such as a persistent corneal epithelial defect, or corneal ulcer.
• Have presence of corneal pathology that may interfere with LASIK outcomes
• Active infectious, ocular or systemic disease
• Have a history of ocular inflammation or macular edema
• Have had clinically significant active infectious keratitis in the past 3 months
• Have history of prior refractive surgery
• Have placement of temporary punctal plugs in the past 1 month or current presence of permanent punctal plugs at time of screening
• 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
• Have a vascularized polyp, severely deviated septum, chronic recurrent nosebleeds, or severe nasal obstruction as confirmed by intranasal examination performed at Visit 1.
• Be currently treated with nasal continuous positive airway pressure
• Have had blepharoplasty in either eye
• Have had a corneal transplant in either eye
• Have a history of seizures or other factors that lower the subject's seizure threshold.
• 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 a known hypersensitivity to any of the procedural agents or study drug components
• 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.
• Have current concomitant use of snuff, chewing tobacco, e-cigarettes or cigarettes/cigars during the study or within the previous 30 days.
• Subject must refrain from smoking during the course of the study.
• Have active or uncontrolled, severe at the discretion of the investigator:
• Systemic allergy
• Chronic seasonal allergies at risk of being active during the study treatment period
• Rhinitis or sinusitis requiring treatment such as antihistamines, decongestants, oral or aerosol steroids at the Screening Visit or be expected to require treatment during the treatment period of the study
• Untreated nasal infection at Visit 1

Where it is running

• Vance Thompson Vision ND — West Fargo, North Dakota, United States

Full record on ClinicalTrials.gov

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