Can a drop of timothy grass unlock the Eye-Nose allergy link?

NCT ID NCT07801625

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
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First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

Researchers at Queen's University are testing a method to safely trigger eye allergies in a research setting. They will apply timothy grass extract to the eyes of allergic and non-allergic volunteers, then measure symptoms and collect tear and nasal fluid samples. The goal is to understand how eye and nose allergies are connected and to develop a consistent model for studying allergic rhinoconjunctivitis.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Timothy grass allergen extract applied to the eye
What this could lead to
If successful, this model could provide a consistent way to study allergic rhinoconjunctivitis and reveal how eye and nose allergies are linked, potentially aiding future treatments.
What could go wrong
This is a small pilot study with only 12 participants, so results may not apply broadly. The challenge may not reliably produce symptoms in all participants, and there is a risk of allergic reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adults between 18 to 70 years old from the Kingston, Frontenac, Lennox, and Addington regions. Participants on file from previous enrolment in Kingston Allergy Research studies may be eligible for the study, if inclusion/exclusion criteria is met. We aim to recruit 6 timothy grass allergic participants and 6 non-allergic controls.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: All participants must be: 1. A volunteer between the ages of 18 to 70 years of age. 2. Able to understand and willing to provide written informed consent. 3. Able and willing to comply with study requirements. 4. If the participant is a person of childbearing potential, they must practice abstinence or use a medically acceptable method of birth control and produce a negative urine pregnancy test at Visit 1, Visit 2, and Visit 3 (only non-allergic participants will require a pregnancy testing at Visit 3). To be enrolled as an allergic participant, participants must: 1. Have a minimum 2-year history of grass-specific allergic rhinoconjunctivitis symptoms upon exposure to the relevant allergen, documented by medical history review at Visit 1. 2. Have a positive skin prick test response to Timothy grass allergen, defined as a wheal diameter ≥ 5 mm compared to the negative control wheal. This test must be performed by the study team either at the Visit 1 or historically within 1 year of Visit 1 at our research site. 3. Have a reported ocular itch ≥2, self-reported ocular redness ≥2, and ophthalmologist/optometrist confirmation of ocular redness (using slit lamp) ≥2 following CAC at Visit 1. To be enrolled as a non-allergic participant, participants must: 1. Produce a negative skin prick test response to a panel of relevant aeroallergens tested at Visit 1 or within 1 year prior to Visit 1 at our research site. 2. Produce a negative CAC, defined by an ocular itch = 0, self-reported ocular redness ≤1, and ophthalmologist/optometrist confirmation of ocular redness (using slit lamp) ≤1 after 10 minutes in response to the lowest (1:512), moderate (1:32) and highest (1:4) concentrations of allergen at Visit 1. Exclusion Criteria: Participants presenting with any of the following will not be included in the study: 1. Participant has a history of any disease or disorder that, in the judgement of the Principal Investigator, would impact on participant's safety or the results of the study. 2. Participant has a significant history of alcohol or drug abuse in the judgment of the Principal Investigator or delegate. 3. Participant is pregnant, lactating, or actively trying to become pregnant. 4. Participant is unable to comply with the washout periods for restricted medications, contact lens use, and smoking. 5. Participant has signs/symptoms of active seasonal AR or is allergic to a seasonal allergen that is present in the outdoor environment during the time of the screening and CAC visits and which the Principal Investigator judges would impact the outcome of the study. If the schedule allows the participant can be re-scheduled for the visit outside the allergy season. 6. Participant has any structural nasal abnormalities, nasal polyps on examination, or a history of frequent nose bleeding, as determined by a nasal examination at screening and prior to the CAC, in the judgement of the Principal Investigator or delegate. 7. Participant has a history or clinically significant findings during the ocular examination of ocular abnormalities (e.g., meibomian gland dysfunction, moderate to severe dry eyes, cicatrizing conjunctivitis, glaucoma) that may affect the outcome of the study in the judgement of the Investigator. 8. Participant has abnormalities detected on physical examination considered by the Principal Investigator to be clinically significant. 9. Participant has undergone nasal surgery within the 3 months before Visit 1. 10. Participant has undergone ocular surgery within the 3 months before Visit 1. 11. Participant has experienced or exhibits any signs or symptoms of an upper respiratory tract infection within 14 days prior to any visit.\* 12. Participant reports a TNSS ≥4 prior to the titration challenge at Visit 1 or immediately prior to allergen challenge at Visit 2, as per PI judgement.\*\* 13. Participant reports ocular itch \> 0 and ocular redness \> 1 and ophthalmologist/optometrist reported redness \> 1 (using slit lamp) in either eye prior to allergen challenge at any visit. 14. Participant reports a TNSS change \> 2 from baseline, after the negative control and diluent challenge at Visit 1. 15. Participant reports ocular itching \> 0 or ocular redness \> 1, or ophthalmologist/optometrist reported redness \>1 (via slit lamp) following challenge with the negative control and diluent control. 16. Participant has a history of allergen induced asthma upon exposure to grass allergen, unless well controlled on low dose inhaled corticosteroids or when required (PRN) inhaled corticosteroid/long-acting beta-agonist as per Principal Investigator judgement. 17. Participants with asthma requiring the use of a short-acting beta agonist greater than twice a week (unless for viral or execise induced asthma) or with severe asthma requiring maintenance high dose of inhaled or oral corticosteroids or biologic therapy (Omalizumab/Tezepelumab/Dupilumab/Mepolizumab/Benralizumab). 18. Participant is currently receiving allergen specific immunotherapy to Timothy grass allergen or concluded a course of grass immunotherapy in the last 3 years. 19. Participant has a history of positive test results for to human immunodeficiency viruses (HIV), Tuberculosis (not due to vaccination), Hepatitis B (not due to vaccination) or Hepatitis C. 20. Participant has received an investigational product within the previous 30 days. 21. Participant is unable and/or unlikely to comprehend and/or follow the protocol over the duration of the study. 22. Participant is unwilling to attend study visits or adhere to the study protocol, in the judgement of the Principal Investigator. 23. Participant has a known hypersensitivity to any excipient in the study formulation. 24. Participant has a history of a severe systemic allergic reaction (e.g., anaphylaxis requiring emergency treatment) to Timothy grass or any grass pollen immunotherapy. 25. Participant is currently receiving treatment for acne (e.g., isotretinoin) or has concluded less than 1 month prior to Visit 1. * Participant may be rescheduled once respiratory infection is cleared \*\*If TNSS≥ 4, participant may be re-booked if appropriate and the schedule permits.

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Conditions

The condition(s) this trial relates to.

allergic rhinitis Conjunctivitis, Allergic Rhinitis, Allergic seasonal allergic rhinitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Kingston Health Sciences Centre - Kingston General Hospital

    Kingston, Ontario, K7L 2V7, Canada

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