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RecruitingNCT06831253ReLIPSSOUpdated Mar 19, 2025

Efficacy of Platelet-Rich Plasma Injection in Dry Eye Syndrome

An interventional study of injections of Platelet-Rich Plasma in lacrimal gland in Severe Dry Eye Syndromes and Dry Eye Syndromes, sponsored by Centre Hospitalier Universitaire de Nice. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-19.

Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as recruiting.
  • Started Mar 2025; still recruiting 1 year 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 the detailed description

injections in lacrimal gland four times during the study for each patient

02

Conditions studied

  • Severe Dry Eye Syndromes
  • Dry Eye Syndromes

Keywords

  • Dry Eye Syndromes
  • lacrimal gland
  • platelet-rich plasma
  • aqueuous deficiency
03

In context

Dry Eye Syndromes

1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.

This study's planned enrollment of 20 is below the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Platelet counts, and clotting factors in the standarts
  • Presenting with severe dry keratoconjunctivitis diagnosed by an ophthalmologist

Exclusion criteria

Exclusion Criteria:

  • Patients with significant fibrosis of the conjunctival portion of the lacrimal gland
  • Patients with complete stenosis of both lacrimal meatus in the treated eye
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Injection of Platelet-Rich Plasma (PRP)

    Other: injections of Platelet-Rich Plasma in lacrimal gland

Interventions

  • Otherinjections of Platelet-Rich Plasma in lacrimal gland

    injections of Platelet-Rich Plasma in lacrimal gland

06

What researchers measure

Primary outcomes

  1. To compare the lacrimal secretion after 4 monthly injections of PRP into the lacrimal gland

    Schirmer I test score between 0mm and more 20mm

    Time frame: 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

    Time frame: week 16

07

Study locations

1 of 1 sites recruiting
  • CHU de Nice
    Nice, Site Principal Investigator 06000, France
    • Jean Philippe Grosse, Dr · Contact · 0492034702
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06831253
Lead sponsor
Centre Hospitalier Universitaire de Nice
Responsible party
Sponsor
First posted
Feb 18, 2025
Start date
Mar 17, 2025
Primary completion
Mar 1, 2026 (estimated)
Completion
Jul 1, 2026 (estimated)
Last update
Mar 19, 2025

Study contacts

Doctor Jean Philippe GROSSE, Dr
Contact
causeret.m@chu-nice.fr
04.92.03.47.02

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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