Investigator Initiated Study to Assess the Efficacy of OC-01 (Varenicline) Nasal Spray on Signs a… (NCT05082974) | Clinical Trial Compass
CompletedPhase 3
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)
United States40 participantsStarted 2021-10-20
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
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…
What they're measuring
1
Change in NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire) score
Timeframe: Baseline to Day 84 (3 months)
2
Mean change in corneal fluorescein staining based on the NEI (National Eye Institute) scale for Corneal Fluorescein Staining determined at slit lamp
Timeframe: Baseline to Surgical Day and from Surgical Day to Day 84 (3-month)