Efficacy of Two Concentrations of Autologous Serum for the Treatment of Severe Dry Eye

• Status: Unknown status
• Trial end date: 2018-11-19
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the effects of autologous serum 20% and autologous serum 50% for the treatment of Severe Dry Eye Syndrome

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pontificia Universidad Catolica de Chile
• Collaborators: Hospital Dr Sotero del Rio; Hospital Dr. Sótero del Río

Criteria

Inclusion Criteria:

• Man/woman ≥ 18 years old, able to freely give consent to participate in the study

• At least 1 of the following tests altered:

• Ocular Surface Disease Index (OSDI) Test symptoms > 32

• BUT ≤5 seconds

• Oxford staining ≥ 3

• Schirmer Test without anesthesia ≤ 5 mm

Exclusion Criteria:

• Sensitivity or known intolerance to any of the products used in the study

• Contraindication of venipuncture

• Story of ocular infections within the 6 previous months to study inclusion

• Any active ocular pathology other than Dry Eye Syndrome

• Use of contact lenses in the 3 previous months to study inclusion

• No pregnant or breastfeeding women is allowed to participate in the study. Childbearing potential women must use contraceptive means during the whole study.

• Participation in another clinical trial in the last 30 days before study inclusion