Autologous Plasma Rich in Growth Factors for Severe Dry Eye Disease
NCT07773740 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2026-08-25
Summary
The goal of this clinical trial is to evaluate the change in dry eye symptoms after the treatment with Plasma Rich in Growth Factors (PRGF) in patients with severe dry eye. The main question it aims to answer is:
Are dry eye simptoms less after the treatment with PRGF?
Researchers will compare standard topical treatment and PRGF with standard topical treatment and placebo to see if there is a difference in dry eye symptoms between arms. Secondary outcomes include changes in tear meniscus height, non invasive tear break-up time, conjunctival hyperemia, meibomian gland dropout and Ocular Staining Score (OSS) scale for corneal and conjunctival damage.
Participants will be asked to use standard treatment and PRGF or placebo for 1 month.
Conditions
- Dry Eye Disease With Severe Keratitis
Interventions
- OTHER
-
PRGF
PRGF eyedrops four times a day for 1 month
- OTHER
-
Balanced Salt Solution (BSS®)
Balanced salt solution 0.09% eyedrops four times a day for 1 month
Sponsors & Collaborators
-
Lansier
collaborator UNKNOWN -
Gladys Lucia Silva Linares
lead OTHER
Principal Investigators
-
Kieran S. O´brien, MD · Seva Foundation
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-25
- Primary Completion
- 2027-08-31
- Completion
- 2027-08-31
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