Characterization of Subjective Discomfort in Patients With Tear Dysfunction

Not yet recruiting

• Conditions: Dry Eye Disease

• Registration Number: NCT06819631
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2025-01-10
• Study First Submitted QC: 2025-02-10
• Last Update Submitted: 2025-02-10
• Study First Posted: 2025-02-11
• Last Update Posted: 2025-02-11
• Study Start: 2025-03
• Primary Completion: 2025-03
• Study Completion: 2029-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 12000

Inclusion Criteria

• adult patients with suspected or diagnosed DED

Exclusion Criteria

• nothing

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy