Autologous Serum Obtained by a Closed-Circuit Collection Device
NCT07014059 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2025-06-10
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.
Conditions
- GVHD
- Meibomian Gland Dysfunction (Disorder)
- Stevens-Johnson Syndrome
- Limbal Keratoconjunctivitis
- Recurrent Erosions of Persistent Epithelial Defects
- Neurotrophic Ulcer
- Sjogren Syndrome With Keratoconjunctivitis
Interventions
- DRUG
-
Autologous Serum 20%
The collection of autologous serum in a closed blood processing system for ocular use
Sponsors & Collaborators
-
JP Farma
collaborator UNKNOWN -
GIANCARLO FATOBENE
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-20
- Primary Completion
- 2026-06-20
- Completion
- 2027-06-20
Countries
- Brazil
Study Locations
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