Trial | NCT03436576  Report issue

Title

Efficacy of Two Concentrations of Autologous Serum for the Treatment of Severe Dry Eye
Comparison of Autologous Serum 20% and Autologous Serum 50% for the Treatment of Severe Dry Eye

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    20
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
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 eye syndrome.
Study Started
Sep 12
2018
Anticipated
Primary Completion
Oct 19
2018
Anticipated
Study Completion
Nov 19
2018
Anticipated
Last Update
Sep 05
2018

Drug Autologous Serum 20%

Instillation of 1 drop of Autologous Serum 20% four times a day

  • Other names: Autologus serum low concentration

Drug Autologous Serum 50%

Instillation of 1 drop of Autologous Serum 50% four times a day

  • Other names: Autologus serum high concentration

Autologous Serum 20% Active Comparator

Treatment with Autologous Serum 20% for 2 months

Autologous Serum 50% Active Comparator

Treatment with Autologous Serum 50% for 2 months

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
No Results Posted