Menu
Not yet recruiting NCT07710846

A Study to Identify and Characterize Adults and Pediatric Participants With Cat and/or Birch Allergy

— Observational Conjunctivitis Allergic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Noninterventional.
Who it may be relevant to
Registry conditions: Conjunctivitis Allergic. Basic parameters: from 5 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Patient Identification and Characterization (PIC) Study: A Prospective, Multicenter, Non-Interventional Study to Identify and Characterize Participants With Allergic Conjunctivitis With or Without Allergic Rhinitis Due to Cat and/or Birch Allergy

Overview

The purpose of this Patient Identification and Characterization (PIC) study is to collect information and perform limited allergy-related procedures to determine if participants can qualify for cat and/or birch tree pollen allergy clinical research studies in the future. The study is also looking at how cat and/or birch tree pollen allergies have affected overall health.

Interventions

  • Other Noninterventional
    No investigational medicinal products will be administered in this study.

Primary outcome measures

  • Proportion of participants with moderate-to-severe allergic conjunctivitis due to cat allergy who report "very bothered" or "extremely bothered" by allergic symptoms upon exposure to cat and/or cat hair/dander [Time frame: At visit 1, up to 30 days]
  • Proportion of participants with moderate-to-severe allergic conjunctivitis due to birch tree pollen allergy who report "very bothered" or "extremely bothered" by allergic symptoms [Time frame: At visit 1, up to 30 days]
Secondary outcome measures (2)
  • Proportion of participants who report "very bothered" or "extremely bothered" by allergic symptoms upon exposure to cat and/or cat hair/dander [Time frame: At visit 1, up to 30 days]
  • Proportions of participants who report "very bothered" or "extremely bothered" by allergic symptoms due to birch tree pollen [Time frame: At visit 1, up to 30 days]

Eligibility criteria

Inclusion criteria

  • Adults or pediatric participants, ≥5 years of age inclusive (pediatric participants ≥5 years and <18 years and weighing ≥10 kg, to be enrolled where permitted per local regulations/approvals), at the time of signing the informed consent
  • Participant-reported (and/or caregiver-reported for pediatric participants) and/or documented allergic history as described in the protocol
  • Positive Skin Prick Test (SPT) at screening: to cat allergen (Part A) and/or to birch allergen (Part B)
  • Must not currently live with a cat(s) or have lived with a cat(s) in the home for the past 1 year (Part A)
  • Willing and able to comply with clinic visit(s) and study-related assessments

Exclusion criteria

  • Presence of any ophthalmic disease/abnormality/condition that may interfere with study assessments, affect the study outcomes or participant safety as described in the protocol
  • History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, and/or hypoxic seizures
  • Active, chronic infections requiring long-term use of systemic antibiotics, antivirals, or anti-fungal treatments

Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07710846 · R1908-1909-ALG-25126

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗