Efficacy of Platelet-Rich Plasma Injection in Dry Eye Syn... | NCT06831253

Studies
Efficacy of Platelet-Rich Plasma Injection in Dry Eye Syndrome

NCT06831253

Sponsor

Centre Hospitalier Universitaire de Nice

Status

Recruiting

Last Update Posted

Mar 19, 2025Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Severe Dry Eye Syndromes
Dry Eye Syndromes

Interventions

injections of Platelet-Rich Plasma in lacrimal gland

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
IDRCB	Other Identifier	2024-A02096-41

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 17, 2025Actual

Primary Completion Date

Mar 1, 2026Estimated

Completion Date

Jul 1, 2026Estimated

First Submitted Date

Feb 7, 2025

First Submission Date that Met QC Criteria

Feb 14, 2025

First Posted Date

Feb 18, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2025

Last Update Posted Date

Mar 19, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Injection of Platelet-Rich Plasma (PRP)	Experimental		Other: injections of Platelet-Rich Plasma in lacrimal gland

Interventions

Name	Type	Description	Arm Group Labels	Other Names
injections of Platelet-Rich Plasma in lacrimal gland	Other	injections of Platelet-Rich Plasma in lacrimal gland	Injection of Platelet-Rich Plasma (PRP)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To compare the lacrimal secretion after 4 monthly injections of PRP into the lacrimal gland	Schirmer I test score between 0mm and more 20mm	week 16

Secondary Outcomes

Measure	Description	Time Frame
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	week 16

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Doctor Jean Philippe GROSSE, Dr	Contact	04.92.03.47.02		causeret.m@chu-nice.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Nice	Recruiting	Nice	Site Principal Investigator	06000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015352	Dry Eye Syndromes

Ancestor Terms

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided