Identifying Atopic Dermatitis Patients at Risk for Developing Conjunctivitis During Dupilumab Treatment

Recruiting

• Conditions: Atopic Dermatitis

• Registration Number: NCT04276623
• Lead Sponsor: UMC Utrecht

Brief Summary

Study on ophthalmological comorbidities and the underlying pathomechanisms of conjunctivitis during dupilumab treatment in atopic dermatitis (AD) patients. Patients participate in the Bioday Registry.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-10
• Study First Submitted QC: 2020-02-17
• Study First Posted: 2020-02-19
• Study Start: 2020-02-25
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Adult patients with atopic dermatitis indicated for dupilumab, without current use of oral immunosuppressive treatment .

Exclusion Criteria

• Treatment with oral or ocular immunosuppressive drugs 2 weeks prior to start of dupilumab treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relationship between goblet cell density and the risk of conjunctivitis	change of goblet cell density between baseline, 4 weeks and 28 weeks after start dupilumab, at the moment of the development of eye symptoms, 4 weeks after ocular treatment	Establish the relationship between goblet cell densitiy and the risk of conjunctivitis during dupilumab treatment in AD patients. Goblet cell density will determined by counting the goblet cells. The amount of goblet cells will be compared at different time points. Goblet cells will be collected using Impression Cytology of the conjunctiva and will be stained directly.
Relationship between goblet cell density and the incidence of conjunctivitis over time	change of goblet cell density between baseline, 4 weeks and 28 weeks after start dupilumab, at the moment of the development of eye symptoms, 4 weeks after ocular treatment	Establish the relationship between goblet cell densitiy and the incidence of conjunctivitis during dupilumab treatment in AD patients. Goblet cell density will determined by counting the goblet cells. The amount of goblet cells will be compared at different time points. Goblet cells will be collected using Impression Cytology of the conjunctiva and will be stained directly.

Secondary Outcome Measures

Name	Time	Method
Optimal treatment of conjunctivitis	at the moment of the development of eye symptoms, 4 weeks after ocular treatment	Establish the most optimal treatment of conjunctivitis during dupilumab treatment. Ophthalmological examination will be compared at all time points to determine if the prescribed therapy is effective and optimal.
Conjunctival changes during dupilumab treatment using Impression Cytology	baseline, 4 weeks and 28 weeks after start dupilumab, at the moment of the development of eye symptoms, 4 weeks after ocular treatment	Better understanding of conjunctival changes using Impression Cytology of the conjunctiva, collected at different time points during treatment with dupilumab in AD patients

Trial Locations

Locations (1)

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands