Status:
ACTIVE_NOT_RECRUITING
Comparing Efficacy of Autologous Serum Eye Drops With and Without Insulin in Autoimmune Dry Eye: A Randomized Clinical Trial
Lead Sponsor:
Instituto de Oftalmología Fundación Conde de Valenciana
Conditions:
Dry Eye
Sjogren Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Introduction: Dry Eye Disease (DED) of autoimmune origin is often severe and resistant to conventional treatments, necessitating alternative therapeutic options. Autologous Serum Eye Drops (ASED) hav...
Detailed Description
Introduction: Dry Eye Disease (DED) of autoimmune origin is often severe and resistant to conventional treatments, necessitating alternative therapeutic options. Autologous Serum Eye Drops (ASED) hav...
Eligibility Criteria
Inclusion
- Inclusion criteria included men and women aged 18 years or older with a diagnosis of primary\[ and secondary SS confirmed by a rheumatologist using the 2016 ACR-EULAR diagnostic criteria, and moderate to severe DED. Moderate to severe DED was classified using the following standardized parameters: Ocular Surface Disease Index (OSDI) ≥ 23 points, ocular surface staining according to the Van Bijsterveld score ≥ 4 points, non-invasive tear break-up time (NITBUT) ≤ 7 seconds, and tear meniscus height (TMH) ≤ 0.3 mm, measured with the Keratograph 5M (Oculus, Wetzlar, Germany). Participants were required to be willing to comply with the study protocol and follow-up schedule.
Exclusion
- Exclusion criteria included participation in another clinical trial in the preceding three weeks, topical use of aminoglycoside antibiotics, therapeutic contact lens use, known hypersensitivity to any component of the study medications, active ocular infection, ocular surgery or trauma within three months, or any abnormality compromising corneal integrity. Additionally, patients with a history of corneal transplantation, pregnancy or lactation, or planned pregnancy were excluded.
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06931041
Start Date
February 1 2024
End Date
June 1 2025
Last Update
April 16 2025
Active Locations (1)
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1
Instituto de Oftalmologia Conde de Valenciana IAP
Mexico City, Mexico, 06800