Ocular Comorbidity in Atopic Dermatitis
1 other identifier
observational
120
1 country
1
Brief Summary
A clinical characterization of a large cohort of patients with different severities of AD and ocular symptoms/atopic keratoconjunktivitis (AKC). The data will contribute to assess the frequency of complications in order to give a rationale for focused prevention and treatment strategy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2021
CompletedFirst Posted
Study publicly available on registry
July 22, 2021
CompletedStudy Start
First participant enrolled
August 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedNovember 15, 2024
November 1, 2024
2.5 years
July 6, 2021
November 13, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Bulbar redness (BR) score
Difference in Bulbar redness (BR) score (Keratograph 5M, R-scan). Scale from 0-4. A higher score indicates more severe BR.
1 day At examination
Secondary Outcomes (21)
Inferior Tear Meniscus Height (TMH)
1 day Cross-sectional at examination (one time)
Non-invasive Keratograph Break-Up Time (NIKBUT)
1 day Cross-sectional at examination (one time)
Meibo-Scan
1 day Cross-sectional at examination (one time)
Ocular surface staining
1 day Cross-sectional at examination (one time)
Osmolarity of the tears
1 day Cross-sectional at examination (one time)
- +16 more secondary outcomes
Eligibility Criteria
AD patients with current or previous ocular symptoms suspected to be atopic keratoconjunctivitis
You may qualify if:
- Danish talking
- Diagnosed with atopic dermatitis (AD)
- Current or previous ocular symptoms suspected to be atopic keratoconjunctivitis
You may not qualify if:
- No pause in eyedrops
- Ocular infections within the last 3 months
- Use of local or systemic antibiotics within the last 3 months
- Significant untreated systemic disease such as hypertension, heart failure, diabetes mellitus, previous cerebral infarction or bleeding, lung diseases and autoimmune diseases other than atopic dermatitis and related comorbidities. The diseases are accepted if they are well treated or do not require treatment
- Current pregnant or breastfeeding
- Use of contact lenses, unless these are paused 2 weeks before the examination or they are due to keratoconus treatment
- If the eye symptoms turn out not to be related to atopic keratoconjunctivitis
- If it is assessed that the individual cannot participate sufficiently for the examination
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rigshospitalet, Denmarklead
- Oslo University Hospitalcollaborator
Study Sites (1)
Department of Ophthalmology, Rigshospitalet-Glostrup
Glostrup Municipality, 2600, Denmark
Biospecimen
Collection of tear samples, brush swabs and conjunctival imprints
Study Officials
- PRINCIPAL INVESTIGATOR
Steffen Heegaard, MD, DMSci
Department of Ophthalmology, Rigshospitalet-Glostrup
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD-student, Coordinating researcher,
Study Record Dates
First Submitted
July 6, 2021
First Posted
July 22, 2021
Study Start
August 5, 2021
Primary Completion
February 14, 2024
Study Completion (Estimated)
December 1, 2026
Last Updated
November 15, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share