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

Study Overview
=================
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 eye syndrome.

Official Title
-----------------
Comparison of Autologous Serum 20% and Autologous Serum 50% for the Treatment of Severe Dry Eye

Conditions
-----------------
Dry Eye, Keratoconjunctivitis Sicca, Sjogren's Syndrome, Corneal Diseases, Conjunctival Diseases, Keratitis, Lacrimal Apparatus Diseases

Intervention / Treatment
-----------------
* Drug: Autologous Serum 20%
* Drug: Autologous Serum 50%


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Autologous Serum 20%<br>Treatment with Autologous Serum 20% for 2 months | Drug: Autologous Serum 20%<br>* Instillation of 1 drop of Autologous Serum 20% four times a day<br>* Other names: Autologus serum low concentration;|
| Active Comparator: Autologous Serum 50%<br>Treatment with Autologous Serum 50% for 2 months | Drug: Autologous Serum 50%<br>* Instillation of 1 drop of Autologous Serum 50% four times a day<br>* Other names: Autologus serum high concentration;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Ocular Surface Disease Index (OSDI) Score | The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire designed to provide a rapid assessment of the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning. The overall OSDI score defines the ocular surface as normal (0-12 points) or as having mild (13-22 points), moderate (23-32 points), or severe (33-100 points) disease. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Tear Break Up Time (TBUT) | The TBUT is based on the time of tear rupture after the instillation of fluorescein. The shorter the time of rupture, the greater the tear dysfunction | 1 week, 1 month, 2 months | 
| Change in Oxford Staining score | The Oxford scale is based on the amount of ocular surface (cornea and conjunctiva) that is stained with lysine or green fluorescein. The severity of the staining points is classified into 6 stages (0-5) from absent to marked epithelial damage. | 1 week, 1 month, 2 months | 
| Change in Schirmer I | It is a tear production test. The Schirmer I test is performed without anesthesia. Two thin strips of filter paper (Whatman 5mm x 35mm) are placed on the bottom of the lower conjunctival sac at the junction of the middle third and the outer third to prevent injury to the cornea. It is recommended to ask the subject to keep their eyes closed to limit the effect of blinking. The strips are kept positioned for 5 minutes and then they are removed and the amount that was moistened is read, in mm. The lower the value, the greater the deficit of tear production | 1 week, 1 month, 2 months | 
| Change in Ocular Surface Disease Index (OSDI) Score | The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire designed to provide a rapid assessment of the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning. The overall OSDI score defines the ocular surface as normal (0-12 points) or as having mild (13-22 points), moderate (23-32 points), or severe (33-100 points) disease. | 1 week, 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autologous serum, Concentration, Autologous serum 20%, Autologous serum 50%, Severe dry eye