- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05082974
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)
June 8, 2023 updated by: Vance Thompson Vision ND
A Randomized, Controlled, Double-Masked, Two-Arm Investigator-Initiated Study to Assess the Efficacy of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease in Subjects Following Laser-assisted in Situ Keratomileusis (LASIK)
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sarah Thiede
- Phone Number: 701-566-5390
- Email: sarah.thiede@vancethompsonvision.com
Study Locations
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North Dakota
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W. Fargo, North Dakota, United States, 58078
- Vance Thompson Vision ND
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Contact:
- Sarah Thiede
- Phone Number: 701-566-5390
- Email: sarah.thiede@vancethompsonvision.com
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Contact:
- Alyson Saville
- Phone Number: 701-566-5390
- Email: alyson.saville@vancethompsonvision.com
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Principal Investigator:
- Michael Greenwod, MD
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Sub-Investigator:
- Nicholas Risbrudt, OD
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Sub-Investigator:
- Brooke Messer, OD
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Sub-Investigator:
- Seth Stofferahn, OD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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 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
- Have any condition or history that, in the opinion of the investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject
- 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 or hysterectomy. A woman that has not had a menses in 12 months or longer is not considered of childbearing potential.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: OC-01 (varenicline 0.6mg/ml) nasal spray
|
OC-01 (varenicline 0.6mg/ml) nasal spray which contains varenicline is being developed by Oyster Point Pharma for the treatment of signs and symptoms of Drye Eye Disease.
OC-01 (varenicline) nasal spray activates the trigeminal parasympathetic pathway and stimulates natural tear production to bathe the corneal nerve endings in a protective layer of tear film.
In addition, OC-01 (varenicline) acts as a cholinergic agonist and may provide analgesia by activating the trigeminal parasympathetic pathway.
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Placebo Comparator: Placebo (vehicle) nasal spray
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Placebo (vehicle) nasal spray [control]
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean change in corneal fluorescein staining based on the NEI (National Eye Institute) scale for Corneal Fluorescein Staining determined at slit lamp
Time Frame: Baseline to Surgical Day and from Surgical Day to Day 84 (3-month)
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Evaluated at slit lamp by a masked physician
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Baseline to Surgical Day and from Surgical Day to Day 84 (3-month)
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Change in NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire) score
Time Frame: Baseline to Day 84 (3 months)
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25 questions to determine overall score of dry eye disease symptoms completed by subject.
Scored from 0-100, with 100 being the highest score and best outcome.
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Baseline to Day 84 (3 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean change in residual refractive error
Time Frame: Day 28 (1-month) postoperative LASIK over time to Day 84 (3-month) postoperative LASIK
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Evaluated by manifest refraction
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Day 28 (1-month) postoperative LASIK over time to Day 84 (3-month) postoperative LASIK
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Change in tear collection lab values
Time Frame: Day 28 (1-month) postoperative LASIK over time to Day 84 (3-month)
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As determined by Schirmer's strips
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Day 28 (1-month) postoperative LASIK over time to Day 84 (3-month)
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Mean change tear break-up time
Time Frame: baseline to Day 0 (Surgical Day), Day 28 (1-month) postoperative LASIK and Day 84 (3-month) postoperative LASIK
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As determined by tear break-up testing
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baseline to Day 0 (Surgical Day), Day 28 (1-month) postoperative LASIK and Day 84 (3-month) postoperative LASIK
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Proportion of subjects treated with rescue dry treatment and/or punctal plugs
Time Frame: Day 84 (3-months) postoperative and Day 168 (6-months) postoperative LASIK
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Determined at follow up appointment by Doctor
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Day 84 (3-months) postoperative and Day 168 (6-months) postoperative LASIK
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Incidence and severity of adverse events
Time Frame: Screening to Day 168 (6-month postoperative LASIK)
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As reported by study coordinators and evaluated by PI
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Screening to Day 168 (6-month postoperative LASIK)
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Change in NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire) score
Time Frame: Baseline to Day 184 (6 months)
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25 questions to determine overall score of dry eye disease symptoms completed by subject.
Scored from 0-100, with 100 being the highest score and best outcome.
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Baseline to Day 184 (6 months)
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Mean change in eye dryness score (EDS)
Time Frame: Baseline to Day 184 (6 months)
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Eye dryness score (EDS) measured by the Visual Analogue Scale (VAS).
Scored from 0-100, with 100 being the worst pain imaginable, and zero no pain.
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Baseline to Day 184 (6 months)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 20, 2021
Primary Completion (Actual)
August 3, 2022
Study Completion (Actual)
August 3, 2022
Study Registration Dates
First Submitted
October 5, 2021
First Submitted That Met QC Criteria
October 5, 2021
First Posted (Actual)
October 19, 2021
Study Record Updates
Last Update Posted (Actual)
June 12, 2023
Last Update Submitted That Met QC Criteria
June 8, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Lacrimal Apparatus Diseases
- Keratoconjunctivitis
- Conjunctivitis
- Conjunctival Diseases
- Keratitis
- Corneal Diseases
- Eye Diseases
- Dry Eye Syndromes
- Keratoconjunctivitis Sicca
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Agents
- Nicotinic Agonists
- Cholinergic Agonists
- Varenicline
Other Study ID Numbers
- The RANK Study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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