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Dry Eye DiseasePhase 3NCT05082974

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)

A Phase 3 study testing OC-01 (varenicline 0.6mg/ml) nasal spray in people with Dry Eye Disease, run by Vance Thompson Vision ND at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). 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
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
40 participants
Where
1 siteUnited States
Study dates
20 Oct 2021to 3 Aug 2022
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 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
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  • 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

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Vance Thompson Vision ND

    West Fargo, North Dakota, 58078

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 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).

Conditions
Dry Eye Disease
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 (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.

  • Placebo (vehicle) nasal sprayDrug

    Placebo (vehicle) nasal spray [control]

Study groups in NCT05082974
Study groupRoleWhat they receive
OC-01 (varenicline 0.6mg/ml) nasal sprayExperimentalNot described
Receives: Drug: OC-01 (varenicline 0.6mg/ml) nasal spray
Placebo (vehicle) nasal sprayPlacebo comparatorNot described
Receives: Drug: Placebo (vehicle) nasal spray

What is being measured

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

  1. 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. Scored from 0-100, with 100 being the highest score and best outcome.

    Measured: Baseline to Day 84 (3 months)

  2. Mean change in corneal fluorescein staining based on the NEI (National Eye Institute) scale for Corneal Fluorescein Staining determined at slit lamp

    Evaluated at slit lamp by a masked physician

    Measured: Baseline to Surgical Day and from Surgical Day to Day 84 (3-month)

Secondary outcomes (7)

  1. 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. Scored from 0-100, with 100 being the highest score and best outcome.

    Measured: Baseline to Day 184 (6 months)

  2. Mean change in eye dryness score (EDS)

    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.

    Measured: Baseline to Day 184 (6 months)

  3. Mean change in residual refractive error

    Evaluated by manifest refraction

    Measured: Day 28 (1-month) postoperative LASIK over time to Day 84 (3-month) postoperative LASIK

  4. Change in tear collection lab values

    As determined by Schirmer's strips

    Measured: Day 28 (1-month) postoperative LASIK over time to Day 84 (3-month)

  5. Mean change tear break-up time

    As determined by tear break-up testing

    Measured: baseline to Day 0 (Surgical Day), Day 28 (1-month) postoperative LASIK and Day 84 (3-month) postoperative LASIK

  6. Proportion of subjects treated with rescue dry treatment and/or punctal plugs

    Determined at follow up appointment by Doctor

    Measured: Day 84 (3-months) postoperative and Day 168 (6-months) postoperative LASIK

  7. Incidence and severity of adverse events

    As reported by study coordinators and evaluated by PI

    Measured: Screening to Day 168 (6-month postoperative LASIK)

Timeline

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

  1. First posted19 Oct 2021
  2. Study start20 Oct 2021
  3. Primary completion3 Aug 2022
  4. Study completion3 Aug 2022

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05082974
Sponsor's protocol ID
The RANK Study
Status last verified
Jun 2023
First submitted
5 Oct 2021
Last updated
12 Jun 2023
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

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 Disease, run by Vance Thompson Vision ND 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 28 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: finished, as of the sponsor's last update on 12 Jun 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. 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: 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?

On the ClinicalTrials.gov record for NCT05082974.

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 12 Jun 2023.

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