Dry EyeNCT06830551
The Effect of Cord Blood Serum Eyes Drops Administer in Patients With Severe Keratopathy Related to EGFR-I Treatment
A study testing administration cord blood based eye drops, standardized to the deliver BDNF. in people with Dry Eye, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The study aim to evaluate the efficacy of cord blood eye drops in the healing of the damaged corneal epithelium. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- administration cord blood based eye drops, standardized to the deliver BDNF.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 12 Sep 2023to 31 Dec 2025
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age over 18 years
- oncology and advanced cancer patients who have EGFr mutation and who require treatment with antiEGFr drugs
- signing of informed consent
Who cannot join
- Patients who are unable to store/administer the CSCO independently, or with the help of care-givers.
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, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
Luigi Fontana, MD, +390512142837, luigi.fontana6@unibo.it
About this study
Official title: Personalized Approach in the Treatment of Patients Affected by Severe Dry Eye Associated With Therapy With EGFR Inhibitors (EGRFR-I) With Growth Factors in Cord Blood Serum (CBS) Eye Drops
The study aim to evaluate the efficacy of cord blood eye drops in the healing of the damaged corneal epithelium.
Read the detailed description
Patients undergoing treatment with EGFR inhibitor for lung cancer might develop corneal damage.
The study aims to evaluate the healing of corneal epithelium by administering cord blood eye drops for one month.
- Conditions
- Dry Eye
- Being tested
- administration cord blood based eye drops, standardized to the deliver BDNF.
- 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.
administration cord blood based eye drops, standardized to the deliver BDNF.Drug
administration cord blood based eye drops customized to deliver epitelio tropic factors, incluiding EGF in EGFR blocked cells
| Study group | Role | What they receive |
|---|---|---|
| eye drops derived from cordonal blood serum | Experimental | patients who are given eye drops Receives: Drug: administration cord blood based eye drops, standardized to the deliver BDNF. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal damage measured with National Eye Institute (NEI) score
Evaluation of the effect of cord blood eye drops administration on the variation of corneal damage in patients with severe keratopathy
Measured: one week before the start of treatment and thirty days after the end of treatment.
Secondary outcomes (3)
Change in discomfort
Symptomatology assessment with OSDI questionnaire. Quality of life analysis with Health-related SF-12 questionnaire, and SEI-QoL subjects' quality of life scale.
Measured: one week before the start of treatment and thirty days after the end of treatment.
Change in quality of life
Change in QOL measured by SF-12 questionnaire
Measured: one week before the start of treatment and thirty days after the end of treatment.
Change in quality of life
Change in QOL measured by SEI-QoL questionnaire
Measured: one week before the start of treatment and thirty days after the end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start12 Sep 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT06830551
- Sponsor's protocol ID
- OFTAFONTANA_DED_EGFR-I
- Other IDs
- F35F22000080001
- Status last verified
- Nov 2024
- First submitted
- 10 Jan 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Approach in the Treatment of Patients Affected by Severe Dry Eye Associated With Therapy With EGFR Inhibitors (EGRFR-I) With Growth Factors in Cord Blood Serum (CBS) Eye Drops
- ClinicalTrials.gov ID
- NCT06830551
- Acronym / sponsor ID
- OFTAFONTANA_DED_EGFR-I
- Conditions
- Dry Eye
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 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.
The study aim to evaluate the efficacy of cord blood eye drops in the healing of the damaged corneal epithelium.
Detailed description
Patients undergoing treatment with EGFR inhibitor for lung cancer might develop corneal damage.
The study aims to evaluate the healing of corneal epithelium by administering cord blood eye drops for one month.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| eye drops derived from cordonal blood serum | Experimental | Drug: administration cord blood based eye drops, standardized to the deliver BDNF.patients who are given eye drops |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age over 18 years
- oncology and advanced cancer patients who have EGFr mutation and who require treatment with antiEGFr drugs
- signing of informed consent
Key exclusion criteria (1 listed)
- Patients who are unable to store/administer the CSCO independently, or with the help of care-givers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| administration cord blood based eye drops, standardized to the deliver BDNF.administration cord blood based eye drops customized to deliver epitelio tropic factors, incluiding EGF in EGFR blocked cells | Drug | eye drops derived from cordonal blood serum |
Primary outcome
Corneal damage measured with National Eye Institute (NEI) score
Time frame: one week before the start of treatment and thirty days after the end of treatment.
Evaluation of the effect of cord blood eye drops administration on the variation of corneal damage in patients with severe keratopathy
3 secondary outcomes
Change in discomfort
Time frame: one week before the start of treatment and thirty days after the end of treatment.
Change in quality of life
Time frame: one week before the start of treatment and thirty days after the end of treatment.
Change in quality of life
Time frame: one week before the start of treatment and thirty days after the end of treatment.
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 17 Feb 2025.
- 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.
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?
A study testing administration cord blood based eye drops, standardized to the deliver BDNF. in people with Dry Eye, 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 3 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: looking for participants now, as of the sponsor's last update on 17 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?
Corneal damage measured with National Eye Institute (NEI) score (time frame: one week before the start of treatment and thirty days after the end of treatment.). 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 17 Feb 2025.