Dry EyePhase 3NCT05045508
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)
A Phase 3 study testing OC-01 (varenicline 0.6mg/ml) nasal spray in people with Dry Eye, run by Brandon Baartman at 1 site in United States.
Trial summary
Evaluate the safety and effectiveness of OC-01 (varenicline) nasal spray among subjects suffering from dry eye following photorefractive keratectomy (PRK) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- OC-01 (varenicline 0.6mg/ml) nasal spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2021to 30 Jan 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Vance Thompson Vision
Omaha, Nebraska, 68137
Sarah Hartnett, 402-899-8020, sarah.hartnett@vancethompsonvision.com
Keeley Puls, 605-371-7075, keeley.puls@vancethompsonvision.com
About this study
Official title: 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)
- Conditions
- Dry Eye
- Being tested
- OC-01 (varenicline 0.6mg/ml) nasal spray, Placebo (vehicle) Nasal Spray
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OC-01 (varenicline 0.6mg/ml) nasal sprayDrug
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 (vehicle) Nasal SprayDrug
Placebo (vehicle) nasal spray [control]
| Study group | Role | What they receive |
|---|---|---|
| OC-01 (varenicline 0.6mg/ml) nasal spray | Experimental | Not described Receives: Drug: OC-01 (varenicline 0.6mg/ml) nasal spray |
| Placebo (vehicle) nasal spray | Placebo comparator | Not described Receives: Drug: Placebo (vehicle) Nasal Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From baseline to day 84 (3 months)
Change in corneal epithelial healing
evaluated at the slit lamp by a masked physician
Measured: from 2 days (48hours) post op to 7 days (1 week) post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start30 Aug 2021
- Primary completion30 Aug 2022 (estimated)
- Study completion30 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brandon Baartman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Brandon Baartman, Vance Thompson Vision NE
- Investigators
- Brandon Baartman, MD, Principal investigator, Vance Thompson Vision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05045508
- Sponsor's protocol ID
- The MyOpe Study
- Status last verified
- Sep 2021
- First submitted
- 7 Sep 2021
- Last updated
- 22 Sep 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05045508
- Acronym / sponsor ID
- The MyOpe Study
- Conditions
- Dry Eye
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Brandon BaartmanUniversity, hospital or other
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 30 Jan 2023 (estimated)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the safety and effectiveness of OC-01 (varenicline) nasal spray among subjects suffering from dry eye following photorefractive keratectomy (PRK)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OC-01 (varenicline 0.6mg/ml) nasal sprayOC-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. | Drug | OC-01 (varenicline 0.6mg/ml) nasal spray |
| Placebo (vehicle) Nasal SprayPlacebo (vehicle) nasal spray [control] | Drug | Placebo (vehicle) nasal spray |
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
Related trials for Dry Eye
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brandon Baartman, MD principal investigator
Vance Thompson Vision
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing OC-01 (varenicline 0.6mg/ml) nasal spray in people with Dry Eye, run by Brandon Baartman at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Hartnett (402-899-8020, sarah.hartnett@vancethompsonvision.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire) score (time frame: From baseline to day 84 (3 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2021.