Dry Eye Disease (DED)NCT06841471
Role of Corneal Nerves in Dry Eye Disease
An observational study of Dry Eye Disease (DED) and Dry Eye, run by Daniela Nosch at 1 site in Switzerland.
Trial summary
This study aims to determine whether corneal nerve function and morphology are affected by tear film instability and ocular surface homeostasis loss. Additionally, it seeks to investigate whether these factors vary based on the severity of dry eye symptoms. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Disease (DED), Dry Eye, Dry Eye Sensation
- How many people
- 140 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Feb 2025to Dec 2025
- How long will I take part?
- 1 Week
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy adults as well as adult with dry eye disease
Who may be able to join
- Group with DED: Diagnosis of DED based on the TFOS DEWS II report
- Group without DED: No diagnosis of DED
Who cannot join
- Systemic disease that may affect ocular health and innervation
- injury or history of operations on the anterior or posterior segment of the eye, which can affect the corneal structure and physiology
- regular application of systemic or ocular medication known to affect the tear film except from DED medications
- eye drops or makeup on the day of measurement.
- Remarks:
- Contact lens wearers are asked not to wear contact lenses for 1 week before the first appointment.
- Participant with DED medications will be asked to use only conservative-free eye drops on the days of examination
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Institute of Optometrym FHNW
Olten, 4600
Daniela S Nosch, BSc MSc PhD, 41629572603, daniela.nosch@fhnw.ch
Emanuele Käser, BSc MSc
About this study
Official title: Association Between Corneal Sensitivity, Nerve Morphology, Tear Film Homeostasis and Dry Eye Symptoms
This study aims to determine whether corneal nerve function and morphology are affected by tear film instability and ocular surface homeostasis loss. Additionally, it seeks to investigate whether these factors vary based on the severity of dry eye symptoms.
- Conditions
- Dry Eye Disease (DED), Dry Eye, Dry Eye Sensation, Corneal Nerve
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | healthy adults | |
| DED group | Adults with Dry Eye following the TFOS DEWS II Diagnosis consensus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences of corneal nerve function and morphology in relation with DED signs
Correlation coefficient between corneal sensitivity and corneal nerve morphology, and variables related to tear film stability and corneal surface homeostasis.
Measured: within one week
Secondary outcomes (1)
Differences of corneal nerve function and morphology in relation with DED symptoms
Correlation coefficient between corneal sensitivity, corneal nerve morphology, and the severity of dry eye symptoms.
Measured: within one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start20 Feb 2025
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry Eye Disease (DED)Studies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Daniela Nosch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daniela Nosch, University of Applied Sciences and Arts Northwestern Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841471
- Sponsor's protocol ID
- 2024-01949
- Other IDs
- 2024-01949
- Status last verified
- Mar 2025
- First submitted
- 17 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Belmonte C, Nichols JJ, Cox SM, Brock JA, Begley CG, Bereiter DA, Dartt DA, Galor A, Hamrah P, Ivanusic JJ, Jacobs DS, McNamara NA, Rosenblatt MI, Stapleton F, Wolffsohn JS. TFOS DEWS II pain and sensation report. Ocul Surf. 2017 Jul;15(3):404-437. doi: 10.1016/j.jtos.2017.05.002. Epub 2017 Jul 20.
PubMed 28736339
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Corneal Sensitivity, Nerve Morphology, Tear Film Homeostasis and Dry Eye Symptoms
- ClinicalTrials.gov ID
- NCT06841471
- Acronym / sponsor ID
- 2024-01949
- Conditions
- Dry Eye Disease (DED), Dry Eye, Dry Eye Sensation, Corneal Nerve
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Daniela NoschUniversity, hospital or other
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 24 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.
This study aims to determine whether corneal nerve function and morphology are affected by tear film instability and ocular surface homeostasis loss. Additionally, it seeks to investigate whether these factors vary based on the severity of dry eye symptoms.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –healthy adults |
| DED group | – | –Adults with Dry Eye following the TFOS DEWS II Diagnosis consensus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy adults as well as adult with dry eye disease
Key inclusion criteria (2 listed)
- Group with DED: Diagnosis of DED based on the TFOS DEWS II report
- Group without DED: No diagnosis of DED
Key exclusion criteria (7 listed)
- Systemic disease that may affect ocular health and innervation
- injury or history of operations on the anterior or posterior segment of the eye, which can affect the corneal structure and physiology
- regular application of systemic or ocular medication known to affect the tear film except from DED medications
- eye drops or makeup on the day of measurement.
- Contact lens wearers are asked not to wear contact lenses for 1 week before the first appointment.
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
Differences of corneal nerve function and morphology in relation with DED signs
Time frame: within one week
Correlation coefficient between corneal sensitivity and corneal nerve morphology, and variables related to tear film stability and corneal surface homeostasis.
1 secondary outcome
Differences of corneal nerve function and morphology in relation with DED symptoms
Time frame: within one week
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 Mar 2025.
- Background: PubMed 28736339Belmonte C, Nichols JJ, Cox SM, Brock JA, Begley CG, Bereiter DA, Dartt DA, Galor A, Hamrah P, Ivanusic JJ, Jacobs DS, McNamara NA, Rosenblatt MI, Stapleton F, Wolffsohn JS. TFOS DEWS II pain and sensation report. Ocul Surf. 2017 Jul;15(3):404-437. doi: 10.1016/j.jtos.2017.05.002. Epub 2017 Jul 20.
- Individual participant dataSharing planned: No
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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.
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 (DED) and Dry Eye, run by Daniela Nosch at 1 site in Switzerland.
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 2 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 11 Mar 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 Switzerland. 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 Daniela S Nosch, BSc MSc PhD (41629572603, daniela.nosch@fhnw.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences of corneal nerve function and morphology in relation with DED signs (time frame: within one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06841471, which also lists 1 linked publication.
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 Mar 2025.