Investigator Initiated Study to Assess the Efficacy of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease Following Photorefractive Keratectomy (PRK)

NCT05045508 | Unknown Phase 3 FDA Drug

• 1 other identifier: The MyOpe Study
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the safety and effectiveness of OC-01 (varenicline) nasal spray among subjects suffering from dry eye following photorefractive keratectomy (PRK)

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (2)

• Change in NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire) score

  25 questions to determine overall score of dry eye disease symptoms completed by subject

  From baseline to day 84 (3 months)

• Change in corneal epithelial healing

  evaluated at the slit lamp by a masked physician

  from 2 days (48hours) post op to 7 days (1 week) post op

Study Arms (2)

OC-01 (varenicline 0.6mg/ml) nasal spray

EXPERIMENTAL

Drug: OC-01 (varenicline 0.6mg/ml) nasal spray

Placebo (vehicle) nasal spray

PLACEBO COMPARATOR

Drug: Placebo (vehicle) Nasal Spray

Interventions

OC-01 (varenicline 0.6mg/ml) nasal spray DRUG

OC-01 nasal spray which contains varenicline is being developed by Oyster Point Pharma for the treatment of signs and symptoms of DED. OC-01 (varenicline) nasal spray activates the trigeminal parasympathetic pathway and stimulates natural tear production and 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.

OC-01 (varenicline 0.6mg/ml) nasal spray

Placebo (vehicle) Nasal Spray DRUG

Placebo (vehicle) nasal spray \[control\]

Placebo (vehicle) nasal spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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 PRK treatment in one or both eyes
• Be myopic between -1.00D to 6.00D manifest refraction spherical equivalent (MRSE) in study eye (right eye) with ≤2D between eyes or subjects undergoing monovision treatment with study eye being the distance eye and meeting the MRSE 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 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 visit and form of birth control will be documented

You may not qualify if:

• Have a break in the integrity of the corneal epithelium such as a persistent corneal epithelial defect or corneal ulcer.
• Have placement of temporary punctal plugs in the past 1 month or current presence of permanent punctal plugs at time of screening
• Presence of corneal pathology that may interfere with PRK outcomes Active infectious, ocular or systemic disease
• Patients with a history of ocular inflammation or macular edema
• Clinically significant active infectious keratitis in the past 3 months
• Have had prior refractive surgery
• 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

Sponsors & Collaborators

• Brandon Baartman: lead

Study Sites (1)

Vance Thompson Vision

Omaha, Nebraska, 68137, United States

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Varenicline; Nasal Sprays

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Aerosols; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Brandon Baartman, MD

  Vance Thompson Vision

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Hartnett

CONTACT

402-899-8020; sarah.hartnett@vancethompsonvision.com

Keeley Puls

CONTACT

605-371-7075; keeley.puls@vancethompsonvision.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Brandon Baartman, Principal Investigator

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 16, 2021
• Study Start: August 30, 2021
• Primary Completion: August 30, 2022
• Study Completion: January 30, 2023
• Last Updated: September 22, 2021

Record last verified: 2021-09

Locations

US (1)