Characterization of Subjective Discomfort in Patients With Tear Dysfunction

February 10, 2025 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

12000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Participants in the study are patients suffering from ocular disconfort who are referred by their doctors for second/third level diagnostic tests at the University Ophthalmology Department. Patients are adults of both sexes, with eventual concomitant systemic and other ocular pathologies, without any limitation that defines exclusion criteria.

Description

Inclusion Criteria:

  • adult patients with suspected or diagnosed DED

Exclusion Criteria:

  • nothing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline (enrollment visit)
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)
Baseline (enrollment visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

  • Principal Investigator: Luigi Fontana, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

January 10, 2025

First Submitted That Met QC Criteria

February 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 10, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OFTAFONTANA_LACSO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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