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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,500
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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
时间窗: 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
时间窗: At visit 1, up to 30 days
Part B
次要结局
- 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)
- 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)