NCT07014059

Brief Summary

Autologous serum eye drops (ASED) are an established therapy for ocular surface diseases; however, their preparation can be costly and may not be available due to the need for germ-free conditions. This pilot trial assesses the feasibility of collecting ASED in a closed-circuit system for patients with chronic ocular surface diseases.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
13mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress44%
Jun 2025Jun 2027

First Submitted

Initial submission to the registry

January 21, 2025

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 10, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

June 20, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2027

Last Updated

June 10, 2025

Status Verified

June 1, 2025

Enrollment Period

1 year

First QC Date

January 21, 2025

Last Update Submit

June 2, 2025

Conditions

GVHDMeibomian Gland Dysfunction (Disorder)Stevens-Johnson SyndromeLimbal KeratoconjunctivitisRecurrent Erosions of Persistent Epithelial DefectsNeurotrophic UlcerSjogren Syndrome With Keratoconjunctivitis

Keywords

soro autologogvhdSjogren's Syndrome (SS)Meibomian Gland Dysfunction (Disorder)Stevens-Johnson SyndromeLimbal KeratoconjunctivitisNeurotrophic UlcerRecurrent Erosions of Persistent Epithelial DefectsStudy Protocol - Autologous SerumAutologous Serum

Outcome Measures

Primary Outcomes (1)

  • Feasibility of using the collection device under testing

    Proportion of blood collections that resulted in successful production of final autologous serum containers suitable for patient use.

    2 years

Secondary Outcomes (18)

  • Median pre-freezing number of leukocytes in autologous serum

    2 years

  • Median pre-freezing number of red blood cells in autologous serum

    2 years

  • Median pre-freezing number of platelets in autologous serum

    2 years

  • Median pre and post-freezing pH in autologous serum

    2 years

  • Pre-freezing microbiological test of autologous serum

    2 years

  • +13 more secondary outcomes

Other Outcomes (1)

  • Pre- and post-growth factor in autologous serum

    two years

Study Arms (1)

Production of autologous serum in a closed system for ocular use

EXPERIMENTAL
Drug: Autologous Serum 20%

Interventions

Autologous Serum 20%DRUG

The collection of autologous serum in a closed blood processing system for ocular use

Production of autologous serum in a closed system for ocular use

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 18 years
  • Dry eye and/or chronic epithelial defects of the ocular surface with indication for autologous serum according to the evaluation of ophthalmologists specialized in Cornea and Ocular Surface;
  • Peripheral venous access or PICC that allows the collection of whole blood.

You may not qualify if:

  • Active ocular infection;
  • Hemoglobin \< 11 g/dL;
  • Angina, MI, or stroke in the last 30 days;
  • Significant pulmonary or cardiac disease that contraindicates autologous serum collection in the investigator's opinion;
  • Active ocular or systemic infection at the time of collection;
  • Inability to attend follow-up visits at 6 and 12 weeks;
  • Active hematological malignancy (except measurable residual disease) or solid malignancy (except non-melanoma skin cancer);
  • Positive for HIV, HCV, HBV, HTLV, Chagas disease, or syphilis;
  • Life expectancy \< 6 months;
  • Not pregnant (as reported by the participant).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HCFMUSP

São Paulo, São Paulo, 05410020, Brazil

Location

MeSH Terms

Conditions

Meibomian Gland DysfunctionStevens-Johnson SyndromeGraft vs Host Disease

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye DiseasesStomatitisMouth DiseasesStomatognathic DiseasesDrug EruptionsDermatitisSkin DiseasesSkin and Connective Tissue DiseasesErythema MultiformeErythemaSkin Diseases, VesiculobullousHypersensitivity, DelayedHypersensitivityImmune System DiseasesDrug HypersensitivityDrug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Central Study Contacts

Giancarlo Fatobene, MD, PhD

CONTACT

+55 (11) 2661-9559giancarlo.fatobene@hc.fm.usp.br

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 21, 2025

First Posted

June 10, 2025

Study Start

June 20, 2025

Primary Completion (Estimated)

June 20, 2026

Study Completion (Estimated)

June 20, 2027

Last Updated

June 10, 2025

Record last verified: 2025-06

Locations

BR(1)