AzTrials
AzTrials

Dry Eye DiseasePhase 2NCT05136924

IIT Assessing OC-01Nasal Spray on Symptoms of DED Following CXL

A Phase 2 study of Dry Eye Disease, run by Vance Thompson Vision - MT at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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 Corneal Collagen Crosslinking (CXL) 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 Disease
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteUnited States
Study dates
1 Dec 2021to 1 Jun 2022
Phase
Phase 2
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
  • Be at least 18 to 50 years of age at the screening visit
  • Have best corrected manifest refraction between 20/40 to 20/100
  • Remove contact lenses 2 weeks prior to surgical procedure and continue until end of study with the exception of scleral lens wearers that have no better option for correcting visual acuity
  • Have planned corneal collagen crosslinking for treatment of keratoconus or corneal ectasia
  • Be literate and able to complete questionnaires independently
Show all 9Show fewer
  • 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/Screening Day

Who cannot join

  • Have presence of corneal pathology that may interfere with CXL outcomes
  • At time of screening have had temporary plugs placed in the past 1 month or currently have permanent punctal plugs in place
  • Active infectious, ocular, or systemic disease
  • Have a history of ocular inflammation or macular edema
  • 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
Show all 21Show fewer
  • 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
  • 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

  • Vance Thompson Vision-MT

    Bozeman, Montana, 59718

    Briana Parker, BS, 406-219-0344, briana.parker@vancethompsonvision.com

    Rachel Hoover, 406 219-0700, rachel.hoover@vancethompsonvision.com

Other trials in United States

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 in Subjects Following Corneal Collagen Crosslinking (CXL)

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 Corneal Collagen Crosslinking (CXL)

Read the detailed description

Rationale for Study Design This study is a single center, prospective, randomized, controlled, double-masked, two-arm investigator-initiated study to investigate the efficacy of OC-01 on signs and symptoms of dry eye disease in subjects following corneal collagen crosslinking (CXL).

  1. STUDY OBJECTIVES 2.1 Primary Objective
  • Mean change in NEI VFQ-25 from baseline to Day 0, Day 7, and Day 28 (1-month postoperative CXL)
  • Coneal epithelial healing rate at days 2 (48 hours), 3 (72 hours), 4 (96 hours) after creation of 9 mm corneal epithelial defect as evaluated by masked physician 2.2 Secondary Objectives
  • Mean change in eye dryness score (EDS) as measured by the Visual Analogue Scale (VAS) from baseline overtime to Day 28 (1 month postoperatively CXL) as measured by masked evaluator
  • Mean change in corneal fluorescein staining from baseline to Day 0 (surgical day) and Day 0 to Day 28 (1-month postoperative CXL) as evaluated by masked physician
  • Mean change in tear break up time (TBUT) from baseline to Day 0 (surgical day) and day 0 to day 28 (1-month postoperative CXL)
  • Incidence and severity of adverse events
Conditions
Dry Eye Disease
Being tested
OC-01 (varenicline 1.2mg/ml) nasal spray vs Placebo, 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 1.2mg/ml) nasal spray vs PlaceboDrug

    Also called Placebo (vehicle) nasal spray

    OC-01 nasal spray containing varenicline for treatment of signs and symptoms of DED. 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 VS Placebo

  • Placebo (vehicle) nasal sprayOther

    Placebo (vehicle) nasal spray

Study groups in NCT05136924
Study groupRoleWhat they receive
OC-01Experimental(varenicline 1.2mg/ml) nasal spray
Receives: Drug: OC-01 (varenicline 1.2mg/ml) nasal spray vs Placebo
PlaceboPlacebo comparator(vehicle) nasal spray
Receives: Other: Placebo (vehicle) nasal spray

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. NEI VFQ-25 Questionnaire

    questionnaire assesses effect of visual impairment on the patient's current health-related quality of life, including questions dealing with irritation in and around the eye. The score on a scale is from 0 to 100 points. A score of 0 is the worst score and a score of 100 is the best score and means the patient has no vision problems

    Measured: from baseline to Day 28 (1-month postoperative CXL)

  2. Corneal Epithelial Healing

    Corneal epithelial healing rate at days 2 (48 hours), 3 (72 hours), 4 (96 hours) after creation of 9mm epithelial defect as measured by a masked physician

    Measured: Up to 96 hours after creation of 9mm epithelial defect

Secondary outcomes (4)

  1. Dryness Scoring

    Mean change in eye dryness score (EDS) as measured by the Visual Analogue Scale (VAS) from baseline over time to Day 28 (1 month postoperatively CXL) as measured by masked evaluator

    Measured: from baseline over time to Day 28 (1 month postoperatively CXL)

  2. Corneal Fluorescein Staining

    Mean change in corneal fluorescein staining from baseline to Day 0 (surgical day) and Day 7 to Day 28 (1-month postoperative CXL) as evaluated by masked physician

    Measured: from baseline to Day 0 (surgical day) and Day 7 to Day 28 (1-month postoperative CXL)

  3. Tear Break Up Time

    Mean change in tear break up time (TBUT) from baseline to Day 0 (surgical day) and Day 7 to Day 28 (1-month postoperative CXL)

    Measured: baseline to Day 0 (surgical day) and Day 7 to Day 28 (1-month postoperative CXL)

  4. Adverse Events

    Incidence and severity of adverse events

    Measured: 56 days (4 weeks preop and 4 weeks postop)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2021
  2. Study start1 Dec 2021 (estimated)
  3. Primary completion1 Jun 2022 (estimated)
  4. Study completion1 Jun 2022 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
OC-01 (varenicline 1.2mg/ml) nasal spray Or Placebo (vehicle) nasal spray
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05136924
Sponsor's protocol ID
The CIrCles Study
Status last verified
Nov 2021
First submitted
7 Oct 2021
Last updated
30 Nov 2021
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Ferguson TJ, Durgan D, Whitt T, Swan RJ. Varenicline Nasal Spray for the Treatment of Dry Eye Disease Following Corneal Collagen Crosslinking. Ophthalmol Ther. 2025 May;14(5):959-968. doi: 10.1007/s40123-025-01118-x. Epub 2025 Mar 15.

    PubMed 40088395

Questions about this trial

What is this clinical trial studying?

A Phase 2 study of Dry Eye Disease, run by Vance Thompson Vision - MT 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 21 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 30 Nov 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

NEI VFQ-25 Questionnaire (time frame: from baseline to Day 28 (1-month postoperative CXL)). 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?

On the ClinicalTrials.gov record for NCT05136924, which also lists 1 linked publication.

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 30 Nov 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in