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

Primary Purpose

Dry Eye, Keratoconjunctivitis Sicca, Sjogren's Syndrome

Status
Unknown status
Phase
Phase 3
Locations
Chile
Study Type
Interventional
Intervention
Autologous Serum 20%
Autologous Serum 50%
Sponsored by
Pontificia Universidad Catolica de Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye focused on measuring Autologous serum, Concentration, Autologous serum 20%, Autologous serum 50%, Severe dry eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital Dr. Sótero del Río

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Autologous Serum 20%

Autologous Serum 50%

Arm Description

Treatment with Autologous Serum 20% for 2 months

Treatment with Autologous Serum 50% for 2 months

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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
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.

Full Information

First Posted
February 12, 2018
Last Updated
August 31, 2018
Sponsor
Pontificia Universidad Catolica de Chile
Collaborators
Hospital Dr Sotero del Rio
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1. Study Identification

Unique Protocol Identification Number
NCT03436576
Brief Title
Efficacy of Two Concentrations of Autologous Serum for the Treatment of Severe Dry Eye
Official Title
Comparison of Autologous Serum 20% and Autologous Serum 50% for the Treatment of Severe Dry Eye
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 12, 2018 (Anticipated)
Primary Completion Date
October 19, 2018 (Anticipated)
Study Completion Date
November 19, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pontificia Universidad Catolica de Chile
Collaborators
Hospital Dr Sotero del Rio

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye, Keratoconjunctivitis Sicca, Sjogren's Syndrome, Corneal Diseases, Conjunctival Diseases, Keratitis, Lacrimal Apparatus Diseases
Keywords
Autologous serum, Concentration, Autologous serum 20%, Autologous serum 50%, Severe dry eye

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Autologous Serum 20%
Arm Type
Active Comparator
Arm Description
Treatment with Autologous Serum 20% for 2 months
Arm Title
Autologous Serum 50%
Arm Type
Active Comparator
Arm Description
Treatment with Autologous Serum 50% for 2 months
Intervention Type
Drug
Intervention Name(s)
Autologous Serum 20%
Other Intervention Name(s)
Autologus serum low concentration
Intervention Description
Instillation of 1 drop of Autologous Serum 20% four times a day
Intervention Type
Drug
Intervention Name(s)
Autologous Serum 50%
Other Intervention Name(s)
Autologus serum high concentration
Intervention Description
Instillation of 1 drop of Autologous Serum 50% four times a day
Primary Outcome Measure Information:
Title
Change in Ocular Surface Disease Index (OSDI) Score
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Change in Tear Break Up Time (TBUT)
Description
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
Time Frame
1 week, 1 month, 2 months
Title
Change in Oxford Staining score
Description
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.
Time Frame
1 week, 1 month, 2 months
Title
Change in Schirmer I
Description
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
Time Frame
1 week, 1 month, 2 months
Title
Change in Ocular Surface Disease Index (OSDI) Score
Description
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.
Time Frame
1 week, 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulina Liberman, MD
Organizational Affiliation
Pontificia Universidad Catolica de Chile
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Dr. Sótero del Río
City
Puente Alto
State/Province
Región Metropolitana
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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