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)

September 15, 2021 updated by: Brandon Baartman

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 Following Photorefractive Keratectomy (PRK)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

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

Study Locations

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

No

Genders Eligible for Study

All

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 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

Exclusion Criteria:

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
  • 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 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
  • Have 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.

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
Drug: OC-01 (varenicline 0.6mg/ml) nasal spray
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.
Placebo Comparator: Placebo (vehicle) nasal spray
Drug: Placebo (vehicle) Nasal Spray
Placebo (vehicle) nasal spray [control]

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire) score
Time Frame: From baseline to day 84 (3 months)
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
Time Frame: from 2 days (48hours) post op to 7 days (1 week) post op
evaluated at the slit lamp by a masked physician
from 2 days (48hours) post op to 7 days (1 week) post op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brandon Baartman

Investigators

  • Principal Investigator: Brandon Baartman, MD, Vance Thompson Vision

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)

August 30, 2021

Primary Completion (Anticipated)

August 30, 2022

Study Completion (Anticipated)

January 30, 2023

Study Registration Dates

First Submitted

September 7, 2021

First Submitted That Met QC Criteria

September 7, 2021

First Posted (Actual)

September 16, 2021

Study Record Updates

Last Update Posted (Actual)

September 22, 2021

Last Update Submitted That Met QC Criteria

September 15, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The MyOpe 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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