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Atopic KeratoconjunctivitisNCT04973384

Ocular Comorbidity in Atopic Dermatitis

An observational study of Atopic Keratoconjunctivitis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Atopic Keratoconjunctivitis
How many people
120 participants
Where
1 siteDenmark
Study dates
5 Aug 2021to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: AD patients with current or previous ocular symptoms suspected to be atopic keratoconjunctivitis

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Department of Ophthalmology, Rigshospitalet-Glostrup

    Glostrup Municipality, 2600

Other trials in Denmark

About this study

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.

Read the detailed description

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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 day At examination

Secondary outcomes (21)

  1. Inferior Tear Meniscus Height (TMH)

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

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

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

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

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

  3. Meibo-Scan

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

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

  4. Ocular surface staining

    Difference in Ocular surface staining

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

  5. Osmolarity of the tears

    Difference in Osmolarity of the tears (TearLab™)

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

  6. Fluorescein tear break up time (TFBUT)

    Difference in Fluorescein tear break up time (TFBUT)

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

  7. Schirmer's I test

    Difference in Schirmer's I test

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

  8. Intraocular pressure (IOP)

    Difference in Intraocular pressure (IOP)

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

  9. Pentacam investigations for detection of keratoconus

    Difference in the frequency of keratoconus

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

  10. Tear cytokine analysis

    Difference in the levels of inflammatory cytokines in the tears

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

  11. Tear proteomic analysis

    Difference in the protein profile in the tears

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

  12. Tear MUC5AC analysis

    Difference in the level of MUC5AC in tears

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

  13. Goblet cell density

    Difference in goblet cells density

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

  14. Microbiome analysis

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

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

  15. Investigation of the infestation of Demodex

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

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

  16. OSDI-score

    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]).

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

  17. PO-SCORAD

    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.

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

  18. POEM

    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.

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

  19. EASI

    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.

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

  20. best-corrected logMAR acuity

    Difference in best-corrected logMAR acuity

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

  21. Slit lamp examination

    Difference in observations with slit lamp

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2021
  2. Study start5 Aug 2021
  3. Primary completion14 Feb 2024
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04973384
Sponsor's protocol ID
H-20069664
Status last verified
Nov 2024
First submitted
6 Jul 2021
Last updated
15 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Atopic Keratoconjunctivitis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bulbar redness (BR) score (time frame: 1 day At examination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04973384.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.

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