Status:
UNKNOWN
Efficacy of Two Concentrations of Autologous Serum for the Treatment of Severe Dry Eye
Lead Sponsor:
Pontificia Universidad Catolica de Chile
Collaborating Sponsors:
Hospital Dr Sotero del Rio
Conditions:
Dry Eye
Keratoconjunctivitis Sicca
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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
Detailed Description
To determine the difference between autologous serum 20% vs 50%, in terms of improvement of symptoms, improvement of ocular surface parameters and acceptable tolerability in patients with severe dry e...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 19 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03436576
Start Date
September 12 2018
End Date
November 19 2018
Last Update
September 5 2018
Active Locations (1)
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1
Hospital Dr. Sótero del Río
Puente Alto, Santiago Metropolitan, Chile