Characterization of Subjective Discomfort in Patients With Tear Dysfunction

NCT ID: NCT06819631

Last Updated: 2025-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

12000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-31

Study Completion Date

2029-06-30

Brief Summary

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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

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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.

Conditions

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Dry Eye Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

* adult patients with suspected or diagnosed DED

Exclusion Criteria

* nothing
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luigi Fontana, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, , Italy

Site Status

Countries

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Italy

Central Contacts

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Luigi Fontana, MD

Role: CONTACT

+390512142837

Facility Contacts

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Luigi Fontana, MD

Role: primary

+390512142837

Other Identifiers

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OFTAFONTANA_LACSO

Identifier Type: -

Identifier Source: org_study_id

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