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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03436576
Other study ID # SERUM2050
Secondary ID
Status Enrolling by invitation
Phase Phase 3
First received
Last updated
Start date September 12, 2018
Est. completion date November 19, 2018

Study information

Verified date August 2018
Source Pontificia Universidad Catolica de Chile
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 20
Est. completion date November 19, 2018
Est. primary completion date October 19, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
Autologous Serum 20%
Instillation of 1 drop of Autologous Serum 20% four times a day
Autologous Serum 50%
Instillation of 1 drop of Autologous Serum 50% four times a day

Locations

Country Name City State
Chile Hospital Dr. Sótero del Río Puente Alto Región Metropolitana

Sponsors (2)

Lead Sponsor Collaborator
Pontificia Universidad Catolica de Chile Hospital Dr. Sótero del Río

Country where clinical trial is conducted

Chile, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
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