Ocular Comorbidity in Atopic Dermatitis

Atopic Keratoconjunctivitis Clinical Trial

Official title:

Ocular Comorbidity in Atopic Dermatitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04973384
• Other study ID #: H-20069664
• Status: Recruiting
• Start date: August 5, 2021
• Est. completion date: June 2024

Study information

• Verified date: November 2023
• Source: Rigshospitalet, Denmark
• Contact: Pernille Rævdal, MD
• Phone: +4520804435
• Email: pernille.raevdal.01[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Atopic Keratoconjunctivitis
• Dermatitis
• Dermatitis, Atopic
• Keratoconjunctivitis

Locations

Country	Name	City	State
Denmark	Department of Ophthalmology, Rigshospitalet-Glostrup	Glostrup

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Oslo University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Inferior Tear Meniscus Height (TMH)	Difference in Inferior Tear Meniscus Height (TMH) (Keratograph 5M)	1 day Cross-sectional at examination (one time)
Secondary	Non-invasive Keratograph Break-Up Time (NIKBUT)	Difference in Non-invasive Keratograph Break-Up Time (NIKBUT) (Keratograph 5M)	1 day Cross-sectional at examination (one time)
Secondary	Meibo-Scan	Difference in Meibo-Scan (Keratograph 5M). Scale from 0-3. A higher score indicates more morphological changes.	1 day Cross-sectional at examination (one time)
Secondary	Ocular surface staining	Difference in Ocular surface staining	1 day Cross-sectional at examination (one time)
Secondary	Osmolarity of the tears	Difference in Osmolarity of the tears (TearLab™)	1 day Cross-sectional at examination (one time)
Secondary	Fluorescein tear break up time (TFBUT)	Difference in Fluorescein tear break up time (TFBUT)	1 day Cross-sectional at examination (one time)
Secondary	Schirmer's I test	Difference in Schirmer's I test	1 day Cross-sectional at examination (one time)
Secondary	Intraocular pressure (IOP)	Difference in Intraocular pressure (IOP)	1 day Cross-sectional at examination (one time)
Secondary	Pentacam investigations for detection of keratoconus	Difference in the frequency of keratoconus	1 day Cross-sectional at examination (one time)
Secondary	Tear cytokine analysis	Difference in the levels of inflammatory cytokines in the tears	1 day Cross-sectional at examination (one time)
Secondary	Tear proteomic analysis	Difference in the protein profile in the tears	1 day Cross-sectional at examination (one time)
Secondary	Tear MUC5AC analysis	Difference in the level of MUC5AC in tears	1 day Cross-sectional at examination (one time)
Secondary	Goblet cell density	Difference in goblet cells density	1 day Cross-sectional at examination (one time)
Secondary	Microbiome analysis	Difference in the amount of different species of the Microbiome of the ocular surface	1 day Cross-sectional at examination (one time)
Secondary	Investigation of the infestation of Demodex	Difference in the amount of Demodex mites in the eyelashes/eyelids with non-invasive in vivo confocal microscopy	1 day Cross-sectional at examination (one time)
Secondary	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]).	1 day Cross-sectional at examination (one time)
Secondary	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.	1 day Cross-sectional at examination (one time)
Secondary	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.	1 day Cross-sectional at examination (one time)
Secondary	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.	1 day Cross-sectional at examination (one time)
Secondary	best-corrected logMAR acuity	Difference in best-corrected logMAR acuity	1 day Cross-sectional at examination (one time)
Secondary	Slit lamp examination	Difference in observations with slit lamp	1 day Cross-sectional at examination (one time)