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NCT Number: NCT06819631

Characterization of Subjective Discomfort in Patients With Tear Dysfunction

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.

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

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

Inclusion criteria

  • adult patients with suspected or diagnosed DED

Exclusion criteria

  • nothing

Treatment and study plan

Primary outcomes

  1. Discomfort in subjects affected by Dry Eye Disease (DED)

    Time frame: Baseline (enrollment visit)

    Assessment of discomfort with Ocular Surface Disease Index (OSDI) and Dry Eye Questionaire-5 (DEQ-5)

  2. Pain in subjects affected by Dry Eye Disease (DED)

    Time frame: Baseline (enrollment visit)

    Assessment of pain with Visual Analogue Scale (VAS) and Numeric Rating Scale (NRS)

Study contacts

Contact information is provided by the study sponsor or research team.

Luigi Fontana, MD

CONTACT

[email protected]

+390512142837

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2029
First posted
Feb 11, 2025
Registry last updated
Feb 11, 2025

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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