Conjunctivitis Allergic
Conditions
Keywords
Cat and/or birch allergen induced allergic conjunctivitis, Cat allergy, Birch pollen allergy, Eye allergy, Cat-induced eye allergy, Ocular allergy signs/symptoms, Allergic conjunctivitis signs/symptoms
Brief summary
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
OTHERNoninterventional
No investigational medicinal products will be administered in this study.
Sponsors
Regeneron Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. 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 2. Participant-reported (and/or caregiver-reported for pediatric participants) and/or documented allergic history as described in the protocol 3. Positive Skin Prick Test (SPT) at screening: to cat allergen (Part A) and/or to birch allergen (Part B) 4. 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) 5. Willing and able to comply with clinic visit(s) and study-related assessments Key
Exclusion criteria
1. 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 2. 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 3. Active, chronic infections requiring long-term use of systemic antibiotics, antivirals, or anti-fungal treatments Note: Other Protocol Defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | At visit 1, up to 30 days | Part A |
| 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 | At visit 1, up to 30 days | Part B |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants who report "very bothered" or "extremely bothered" by allergic symptoms upon exposure to cat and/or cat hair/dander | At visit 1, up to 30 days | Part A |
| Proportions of participants who report "very bothered" or "extremely bothered" by allergic symptoms due to birch tree pollen | At visit 1, up to 30 days | Part B |
Contacts
CONTACTClinical Trials Administrator
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed