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

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

Study Overview

• Status: Unknown
• Conditions: Dry Eye; Keratoconjunctivitis Sicca; Lacrimal Apparatus Diseases; Conjunctival Diseases; Keratitis; Corneal Diseases; Sjogren's Syndrome
• Intervention / Treatment: Drug: Autologous Serum 20%; Drug: Autologous Serum 50%

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 3

Contacts and Locations

Study Locations

• Chile
  • Región Metropolitana
    • Puente Alto, Región Metropolitana, Chile
      • Hospital Dr. Sotero del Rio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Autologous Serum 20%; Treatment with Autologous Serum 20% for 2 months	Drug: Autologous Serum 20%; Instillation of 1 drop of Autologous Serum 20% four times a day; Other Names: Autologus serum low concentration
Active Comparator: Autologous Serum 50%; Treatment with Autologous Serum 50% for 2 months	Drug: Autologous Serum 50%; Instillation of 1 drop of Autologous Serum 50% four times a day; 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

Collaborators and Investigators

• Sponsor: Pontificia Universidad Catolica de Chile
• Collaborators: Hospital Dr Sotero del Rio
• Investigators: Principal Investigator: Paulina Liberman, MD, Pontificia Universidad Catolica de Chile

Study record dates

Study Major Dates

• Study Start (Anticipated): September 12, 2018
• Primary Completion (Anticipated): October 19, 2018
• Study Completion (Anticipated): November 19, 2018

Study Registration Dates

• First Submitted: February 12, 2018
• First Submitted That Met QC Criteria: February 15, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): September 5, 2018
• Last Update Submitted That Met QC Criteria: August 31, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Concentration; Autologous serum; Autologous serum 20%; Autologous serum 50%; Severe dry eye
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Eye Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Conjunctivitis; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Keratitis; Sjogren's Syndrome; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Corneal Diseases; Conjunctival Diseases
• Other Study ID Numbers: SERUM2050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No