Dry Eye DiseaseNCT06819631
Characterization of Subjective Discomfort in Patients With Tear Dysfunction
An observational study of Dry Eye Disease, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease
- How many people
- 12,000 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2025to 30 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- adult patients with suspected or diagnosed DED
Who cannot join
- nothing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
Luigi Fontana, MD, +390512142837, luigi.fontana6@unibo.it
About this study
Official 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
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.
Read the 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.
- Conditions
- Dry Eye Disease
- Medical subject headings
- Dry Eye Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
Discomfort in subjects affected by Dry Eye Disease (DED)
Assessment of discomfort with Ocular Surface Disease Index (OSDI) and Dry Eye Questionaire-5 (DEQ-5)
Measured: Baseline (enrollment visit)
Pain in subjects affected by Dry Eye Disease (DED)
Assessment of pain with Visual Analogue Scale (VAS) and Numeric Rating Scale (NRS)
Measured: Baseline (enrollment visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study startMar 2025 (estimated)
- Primary completionMar 2025 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 12,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luigi Fontana, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819631
- Sponsor's protocol ID
- OFTAFONTANA_LACSO
- Status last verified
- Oct 2024
- First submitted
- 10 Jan 2025
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06819631
- Acronym / sponsor ID
- OFTAFONTANA_LACSO
- Conditions
- Dry Eye Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- adult patients with suspected or diagnosed DED
Key exclusion criteria (1 listed)
- nothing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luigi Fontana, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye Disease, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luigi Fontana, MD (+390512142837, luigi.fontana6@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discomfort in subjects affected by Dry Eye Disease (DED) (time frame: Baseline (enrollment visit)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.