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NCT Number: NCT04973384

Ocular Comorbidity in Atopic Dermatitis

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.

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This study is active but is not currently recruiting participants.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Ophthalmology, Rigshospitalet-Glostrup

Glostrup Municipality, 2600, Denmark

About this study

Atopic Dermatitis (AD), a very common inflammatory skin condition of child and adulthood, is strongly associated with ocular disease. Accordingly, about 20% experience conjunctivitis at some point, and many have chronic disease. Atopic keratoconjunctivitis (AKC) is the most feared as it may lead to blindness. Little is known about the etiology, the immune infiltrate, as well as predictive factors of AKC and the clinical characteristics of AD patients who develop this entity. We expect this project to enable clinicians to better identify AKC patients in the future as well as improve the understanding of the pathogenesis of AKC.

The ocular findings will be compared between AD severity and a control group without ocular symptoms.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Danish talking
  • Diagnosed with atopic dermatitis (AD)
  • Current or previous ocular symptoms suspected to be atopic keratoconjunctivitis

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Bulbar redness (BR) score

    Time frame: 1 day At examination

    Difference in Bulbar redness (BR) score (Keratograph 5M, R-scan). Scale from 0-4. A higher score indicates more severe BR.

Secondary outcomes

  1. Inferior Tear Meniscus Height (TMH)

    Time frame: 1 day Cross-sectional at examination (one time)

    Difference in Inferior Tear Meniscus Height (TMH) (Keratograph 5M)

  2. Non-invasive Keratograph Break-Up Time (NIKBUT)

    Time frame: 1 day Cross-sectional at examination (one time)

    Difference in Non-invasive Keratograph Break-Up Time (NIKBUT) (Keratograph 5M)

  3. Meibo-Scan

    Time frame: 1 day Cross-sectional at examination (one time)

    Difference in Meibo-Scan (Keratograph 5M). Scale from 0-3. A higher score indicates more morphological changes.

  4. Ocular surface staining

    Time frame: 1 day Cross-sectional at examination (one time)

    Difference in Ocular surface staining

  5. Osmolarity of the tears

    Time frame: 1 day Cross-sectional at examination (one time)

    Difference in Osmolarity of the tears (TearLab™)

  6. Fluorescein tear break up time (TFBUT)

    Time frame: 1 day Cross-sectional at examination (one time)

    Difference in Fluorescein tear break up time (TFBUT)

  7. Schirmer's I test

    Time frame: 1 day Cross-sectional at examination (one time)

    Difference in Schirmer's I test

  8. Intraocular pressure (IOP)

    Time frame: 1 day Cross-sectional at examination (one time)

    Difference in Intraocular pressure (IOP)

  9. Pentacam investigations for detection of keratoconus

    Time frame: 1 day Cross-sectional at examination (one time)

    Difference in the frequency of keratoconus

  10. Tear cytokine analysis

    Time frame: 1 day Cross-sectional at examination (one time)

    Difference in the levels of inflammatory cytokines in the tears

  11. Tear proteomic analysis

    Time frame: 1 day Cross-sectional at examination (one time)

    Difference in the protein profile in the tears

  12. Tear MUC5AC analysis

    Time frame: 1 day Cross-sectional at examination (one time)

    Difference in the level of MUC5AC in tears

  13. Goblet cell density

    Time frame: 1 day Cross-sectional at examination (one time)

    Difference in goblet cells density

  14. Microbiome analysis

    Time frame: 1 day Cross-sectional at examination (one time)

    Difference in the amount of different species of the Microbiome of the ocular surface

  15. Investigation of the infestation of Demodex

    Time frame: 1 day Cross-sectional at examination (one time)

    Difference in the amount of Demodex mites in the eyelashes/eyelids with non-invasive in vivo confocal microscopy

  16. OSDI-score

    Time frame: 1 day Cross-sectional at examination (one time)

    Difference in the Ocular Surface Disease Index (OSDI) score. A 12-item questionnaire that gives a score on a scale from 0 to 100, where higher scores represent greater disability (mild [13-22 points], moderate [23-32 points], and severe [33-100 points]).

  17. PO-SCORAD

    Time frame: 1 day Cross-sectional at examination (one time)

    Difference in the Patient-Oriented SCORing of Atopic Dermatitis (POSCORAD) score. A validated self-assessment tool to clinical evaluate AD severity, using subjective and objective criteria. A higher score indicates more severe AD.

  18. POEM

    Time frame: 1 day Cross-sectional at examination (one time)

    Difference in the Patient Oriented Eczema Measure (POEM) score. A validated self-assessment tool to clinical evaluate AD severity. A scale from 0-28. A higher score indicates more severe AD.

  19. EASI

    Time frame: 1 day Cross-sectional at examination (one time)

    Difference in Eczema Area and Severity Index (EASI) score. A tool used to measure the extent (area) and severity of atopic eczema. A scale from 0-72. A higher score indicates more severe AD.

  20. best-corrected logMAR acuity

    Time frame: 1 day Cross-sectional at examination (one time)

    Difference in best-corrected logMAR acuity

  21. Slit lamp examination

    Time frame: 1 day Cross-sectional at examination (one time)

    Difference in observations with slit lamp

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Oslo University Hospital

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Jul 22, 2021
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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