NCT03436576

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

September 12, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2018

Completed
Last Updated

September 5, 2018

Status Verified

August 1, 2018

Enrollment Period

1 month

First QC Date

February 12, 2018

Last Update Submit

August 31, 2018

Conditions

Dry EyeKeratoconjunctivitis SiccaSjogren's SyndromeCorneal DiseasesConjunctival DiseasesKeratitisLacrimal Apparatus Diseases

Keywords

Autologous serumConcentrationAutologous serum 20%Autologous serum 50%Severe dry eye

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in Tear Break Up Time (TBUT)

    1 week, 1 month, 2 months

  • Change in Oxford Staining score

    1 week, 1 month, 2 months

  • Change in Schirmer I

    1 week, 1 month, 2 months

  • Change in Ocular Surface Disease Index (OSDI) Score

    1 week, 2 months

Study Arms (2)

Autologous Serum 20%

ACTIVE COMPARATOR

Treatment with Autologous Serum 20% for 2 months

Drug: Autologous Serum 20%

Autologous Serum 50%

ACTIVE COMPARATOR

Treatment with Autologous Serum 50% for 2 months

Drug: Autologous Serum 50%

Interventions

Autologous Serum 20%DRUG

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

Also known as: Autologus serum low concentration
Autologous Serum 20%
Autologous Serum 50%DRUG

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

Also known as: Autologus serum high concentration
Autologous Serum 50%

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Sensitivity or known intolerance to any of the products used in the study
  • Contraindication of venipuncture
  • Any active ocular pathology other than Dry Eye Syndrome
  • No pregnant or breastfeeding women is allowed to participate in the study. Childbearing potential women must use contraceptive means during the whole study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Dr. Sótero del Río

Puente Alto, Santiago Metropolitan, Chile

Location

MeSH Terms

Conditions

Dry Eye SyndromesKeratoconjunctivitis SiccaSjogren's SyndromeCorneal DiseasesConjunctival DiseasesKeratitisLacrimal Apparatus Diseases

Condition Hierarchy (Ancestors)

Eye DiseasesKeratoconjunctivitisConjunctivitisArthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Paulina Liberman, MD

    Pontificia Universidad Catolica de Chile

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2018

First Posted

February 19, 2018

Study Start

September 12, 2018

Primary Completion

October 19, 2018

Study Completion

November 19, 2018

Last Updated

September 5, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

CL(1)