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

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03436576
• Other study ID #: SERUM2050
• Status: Enrolling by invitation
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Conjunctival Diseases
• Corneal Diseases
• Dry Eye
• Dry Eye Syndromes
• Keratitis
• Keratoconjunctivitis
• Keratoconjunctivitis Sicca
• Lacrimal Apparatus Diseases
• Sjogren's Syndrome

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