Conjunctival Diseases, Corneal Diseases, Dry Eye, Keratitis, Keratoconjunctivitis Sicca, Lacrimal Apparatus Diseases, Sjogren's Syndrome
Conditions
Keywords
Autologous serum, Concentration, Autologous serum 20%, Autologous serum 50%, Severe dry eye
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.
Interventions
Instillation of 1 drop of Autologous Serum 20% four times a day
DRUGAutologous Serum 50%
Instillation of 1 drop of Autologous Serum 50% four times a day
Sponsors
Hospital Dr Sotero del Rio
Pontificia Universidad Catolica de Chile
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Ocular Surface Disease Index (OSDI) Score | 1 month | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Tear Break Up Time (TBUT) | 1 week, 1 month, 2 months | 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 |
| Change in Oxford Staining score | 1 week, 1 month, 2 months | 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. |
| Change in Schirmer I | 1 week, 1 month, 2 months | 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 |
| Change in Ocular Surface Disease Index (OSDI) Score | 1 week, 2 months | 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. |
Countries
Chile
Outcome results
None listed