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

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ClinicalTrials.gov Identifier: NCT03436576
Recruitment Status : Enrolling by invitation
First Posted : February 16, 2018
Last Update Posted : September 5, 2018
Sponsor:
Collaborator:
Hospital Dr. Sótero del Río
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile

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

Condition or disease Intervention/treatment Phase
Dry Eye Keratoconjunctivitis Sicca Sjogren's Syndrome Corneal Diseases Conjunctival Diseases Keratitis Lacrimal Apparatus Diseases Drug: Autologous Serum 20% Drug: Autologous Serum 50% Phase 3

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  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Autologous Serum 20% and Autologous Serum 50% for the Treatment of Severe Dry Eye
Estimated Study Start Date : September 12, 2018
Estimated Primary Completion Date : October 19, 2018
Estimated Study Completion Date : November 19, 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Autologus serum high concentration




Primary Outcome Measures :
  1. Change in Ocular Surface Disease Index (OSDI) Score [ Time Frame: 1 month ]

    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 :
  1. Change in Tear Break Up Time (TBUT) [ Time Frame: 1 week, 1 month, 2 months ]

    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


  2. Change in Oxford Staining score [ Time Frame: 1 week, 1 month, 2 months ]
    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.

  3. Change in Schirmer I [ Time Frame: 1 week, 1 month, 2 months ]

    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


  4. Change in Ocular Surface Disease Index (OSDI) Score [ Time Frame: 1 week, 2 months ]

    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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03436576


Locations
Chile
Hospital Dr. Sótero del Río
Puente Alto, Región Metropolitana, Chile
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Hospital Dr. Sótero del Río
Investigators
Principal Investigator: Paulina Liberman, MD Pontificia Universidad Catolica de Chile

Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT03436576     History of Changes
Other Study ID Numbers: SERUM2050
First Posted: February 16, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pontificia Universidad Catolica de Chile:
Autologous serum
Concentration
Autologous serum 20%
Autologous serum 50%
Severe dry eye

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Sjogren's Syndrome
Keratitis
Keratoconjunctivitis
Corneal Diseases
Conjunctival Diseases
Lacrimal Apparatus Diseases
Conjunctivitis
Eye Diseases
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases