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Efficacy of Two Concentrations of Autologous Serum for the Treatment of Severe Dry Eye | Clinical Trials | Clareo Health

UNKNOWNPHASE3

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

NCT03436576•Pontificia Universidad Catolica de Chile

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Hospital Dr. Sótero del Río

Puente Alto, Santiago Metropolitan, Chile

Key Dates

Start Date

September 12, 2018

Primary Completion Date

October 19, 2018

Completion Date

November 19, 2018

Last Updated

September 5, 2018

Enrollment

ESTIMATED participants

Conditions

Dry EyeKeratoconjunctivitis SiccaSjogren's SyndromeCorneal DiseasesConjunctival DiseasesKeratitisLacrimal Apparatus Diseases

Interventions

Autologous Serum 20%

DRUG

Autologous Serum 50%

DRUG

A Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears: the FOCUS Study

NCT07463950

Dry Eye Disease (DED)

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RECRUITINGPHASE1

A Clinical Study of TI-0032-III Injection in Patients With Relapsed and Refractory Autoimmune Diseases

NCT07413341

Systemic Lupus Erythematosus (SLE)Sjogren's Syndrome (SS)+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 5, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears: the FOCUS Study

A Clinical Study of TI-0032-III Injection in Patients With Relapsed and Refractory Autoimmune Diseases

Rheumatology Patient Registry and Biorepository

A Study on the Correlation Between Tear Iron Levels and the Severity of Dry Eye Disease.

Supplementary Kelulut Honey Therapy in Juvenile Open-Angle Glaucoma: Effects on IL-6, RNFL and Dry Eye

Preliminary Clinical Study of the Effectiveness and Safety of Ocular Surface Microbiota Transplantation in the Treatment of Dry Eye Disease