Severe Dry Eye SyndromesReLIPSSONCT06831253
Efficacy of Platelet-Rich Plasma Injection in Dry Eye Syndrome
A study testing injections of Platelet-Rich Plasma in lacrimal gland in people with Severe Dry Eye Syndromes and Dry Eye Syndromes, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The investigatror wants to show the efficacy of Platelet-Rich Plasma injection in lacrimal gland to restore the lacrimal secretion in patients presenting aqueous deficiency reponsible for severe dry eye syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Dry Eye Syndromes, Dry Eye Syndromes
- What is being tested?
- injections of Platelet-Rich Plasma in lacrimal gland
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 17 Mar 2025to 1 Jul 2026
- 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
- Platelet counts, and clotting factors in the standarts
- Presenting with severe dry keratoconjunctivitis diagnosed by an ophthalmologist
Who cannot join
- Patients with significant fibrosis of the conjunctival portion of the lacrimal gland
- Patients with complete stenosis of both lacrimal meatus in the treated eye
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nice
Nice, Site Principal Investigator, 06000
Jean Philippe Grosse, Dr, 0492034702
About this study
Official title: Efficacy of Restoration of Lacrimal Secretion After Injection of Platelet-Rich Plasma (PRP) Into the Lacrimal Gland in Severe Dry Eye Syndromes (ReLIPSSO)
The investigatror wants to show the efficacy of Platelet-Rich Plasma injection in lacrimal gland to restore the lacrimal secretion in patients presenting aqueous deficiency reponsible for severe dry eye syndrome.
Read the detailed description
injections in lacrimal gland four times during the study for each patient
- Conditions
- Severe Dry Eye Syndromes, Dry Eye Syndromes
- Being tested
- injections of Platelet-Rich Plasma in lacrimal gland
- Keywords
- Dry Eye Syndromes, lacrimal gland, platelet-rich plasma, aqueuous deficiency
- 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.
injections of Platelet-Rich Plasma in lacrimal glandOther
injections of Platelet-Rich Plasma in lacrimal gland
| Study group | Role | What they receive |
|---|---|---|
| Injection of Platelet-Rich Plasma (PRP) | Experimental | Not described Receives: Other: injections of Platelet-Rich Plasma in lacrimal gland |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the lacrimal secretion after 4 monthly injections of PRP into the lacrimal gland
Schirmer I test score between 0mm and more 20mm
Measured: week 16
Secondary outcomes (1)
To compare the different clinical follow-up parameters of qualitative dry ocular syndrome and quantitative after 4 monthly injections of PRP into the lacrimal gland
Ocular Surface Diseases Index (OSDI) a scale of 0 to 100
Measured: week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start17 Mar 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Dry Eye SyndromesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831253
- Sponsor's protocol ID
- 24-AOIP-02
- Other IDs
- IDRCB
- Acronym
- ReLIPSSO
- Status last verified
- Mar 2025
- First submitted
- 7 Feb 2025
- Last updated
- 19 Mar 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 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Restoration of Lacrimal Secretion After Injection of Platelet-Rich Plasma (PRP) Into the Lacrimal Gland in Severe Dry Eye Syndromes (ReLIPSSO)
- ClinicalTrials.gov ID
- NCT06831253
- Acronym / sponsor ID
- ReLIPSSO / 24-AOIP-02
- Conditions
- Severe Dry Eye Syndromes, Dry Eye Syndromes
- Keywords
- Dry Eye Syndromes, lacrimal gland, platelet-rich plasma, aqueuous deficiency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 18 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 investigatror wants to show the efficacy of Platelet-Rich Plasma injection in lacrimal gland to restore the lacrimal secretion in patients presenting aqueous deficiency reponsible for severe dry eye syndrome.
Detailed description
injections in lacrimal gland four times during the study for each patient
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Injection of Platelet-Rich Plasma (PRP) | Experimental | Other: injections of Platelet-Rich Plasma in lacrimal gland |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Platelet counts, and clotting factors in the standarts
- Presenting with severe dry keratoconjunctivitis diagnosed by an ophthalmologist
Key exclusion criteria (2 listed)
- Patients with significant fibrosis of the conjunctival portion of the lacrimal gland
- Patients with complete stenosis of both lacrimal meatus in the treated eye
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 |
|---|---|---|
| injections of Platelet-Rich Plasma in lacrimal glandinjections of Platelet-Rich Plasma in lacrimal gland | Other | Injection of Platelet-Rich Plasma (PRP) |
Primary outcome
To compare the lacrimal secretion after 4 monthly injections of PRP into the lacrimal gland
Time frame: week 16
Schirmer I test score between 0mm and more 20mm
1 secondary outcome
To compare the different clinical follow-up parameters of qualitative dry ocular syndrome and quantitative after 4 monthly injections of PRP into the lacrimal gland
Time frame: week 16
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 19 Mar 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing injections of Platelet-Rich Plasma in lacrimal gland in people with Severe Dry Eye Syndromes and Dry Eye Syndromes, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 2 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 19 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 France. 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 Doctor Jean Philippe GROSSE, Dr (04.92.03.47.02, causeret.m@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the lacrimal secretion after 4 monthly injections of PRP into the lacrimal gland (time frame: week 16). 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 19 Mar 2025.