Skip to content

Characterization of Subjective Discomfort in Patients With Tear Dysfunction

Retrospective and Observational Study in Relation to the Subjective Pain of Patients Attending the Corneal and Ocularcsurface Analysis Laboratory (LACSO) Affected by Ocular Surface Dysfunctions

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06819631
Enrollment
12000
Registered
2025-02-11
Start date
2025-03-31
Completion date
2029-06-30
Last updated
2025-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Disease

Brief summary

Characterization of subjective discomfort/pain in patients with ocular surface dysfunction in association with clinical and laboratory parameters, for a better understanding of the underlying pathogenic mechanisms.

Detailed description

Dry Eye Disease (DED) is a multifactorial chronic disease impairing the ocular surface. DED can be associated with conditions of inflammation and neurosensory dysfunction. The aim of this study is to characterize the discomfort/pain in subjects affected by DED with the administration of scales, questionnaires, and analysis of corneal sensitivity by keratoesthesiometry, in association with clinical laboratory parameters.

Interventions

None listed

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* adult patients with suspected or diagnosed DED

Exclusion criteria

* nothing

Design outcomes

Primary

MeasureTime frameDescription
Discomfort in subjects affected by Dry Eye Disease (DED)Baseline (enrollment visit)Assessment of discomfort with Ocular Surface Disease Index (OSDI) and Dry Eye Questionaire-5 (DEQ-5)
Pain in subjects affected by Dry Eye Disease (DED)Baseline (enrollment visit)Assessment of pain with Visual Analogue Scale (VAS) and Numeric Rating Scale (NRS)

Countries

Italy

Contacts

Primary ContactLuigi Fontana, MD
luigi.fontana6@unibo.it+390512142837

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026