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Autologous Serum Efficacy Study in Patients With Severe Dry Eye

Primary Purpose

Dry Eye

Status
Completed
Phase
Phase 2
Locations
Chile
Study Type
Interventional
Intervention
Autologous serum - Systane
Systane - Autologous serum
Sponsored by
University of Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye focused on measuring Dry eye, Autologous serum, Ocular Surface Disease Index

Eligibility Criteria

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

Inclusion Criteria:

  • Age > 18 years
  • Severe Dry Eye, as defined by a OSDI score > or = 40

Plus:

  • Tear Break Up Time (TBUT) < 5 seconds
  • Cornea-conjunctival epithelial defects measured by Fluorescein staining and evaluation using the Oxford score.

Exclusion Criteria:

  • No dry eye associated ocular disease
  • Unable to comply protocol
  • Severe anemia
  • Previous use of autologous serum
  • Concomitant use of other topical ocular drug
  • Hypersensibility to any proposed interventions

Sites / Locations

  • University Of Chile Clinical Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Autologous serum -Systane

Systane- Autologous serum

Arm Description

Crossover arm starting with autologous serum for 2 weeks. After a 1 week wash out with 0.9% sodium chloride, they continue with 2 weeks using artificial tears (Systane)

Crossover arm starting with artificial tears (Systane) for 2 weeks. After a 1 week wash out with 0.9% sodium chloride, they continue with 2 weeks using autologous serum.

Outcomes

Primary Outcome Measures

To compare the score reduction in the Ocular Surface Disease Index (OSDI) between patients treated with autologous serum and conventional artificial tears.

Secondary Outcome Measures

To compare variations in objective eye measurements, such as Tear Break Up Time and corneal-conjunctival staining according to the Oxford Score, in patients treated with autologous serum and conventional artificial tears.

Full Information

First Posted
October 22, 2008
Last Updated
December 2, 2008
Sponsor
University of Chile
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1. Study Identification

Unique Protocol Identification Number
NCT00779987
Brief Title
Autologous Serum Efficacy Study in Patients With Severe Dry Eye
Official Title
Autologous Serum Efficacy Study in Patients With Severe Dry Eye
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Chile

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare the reduction in symptomatology of patients with severe dry eye treated with autologous serum and conventional artificial tears.
Detailed Description
Severe dry eye remains an important and frequent eye disease, that reflects in a severe impairment of the patient´s life quality. Up to date there is no ideal therapy for this condition. Few studies have reported some kind of improvement in different parameters related to dry eye with the use of autologous serum, but no one has considered the patient´s symptoms with a systematic and validated evaluation method.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
Dry eye, Autologous serum, Ocular Surface Disease Index

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autologous serum -Systane
Arm Type
Other
Arm Description
Crossover arm starting with autologous serum for 2 weeks. After a 1 week wash out with 0.9% sodium chloride, they continue with 2 weeks using artificial tears (Systane)
Arm Title
Systane- Autologous serum
Arm Type
Other
Arm Description
Crossover arm starting with artificial tears (Systane) for 2 weeks. After a 1 week wash out with 0.9% sodium chloride, they continue with 2 weeks using autologous serum.
Intervention Type
Drug
Intervention Name(s)
Autologous serum - Systane
Intervention Description
20% autologous serum solution used four times a day for two weeks. Then 0.9% sodium chloride four times a day for one week. Finally, Systane (r) four times a day for two weeks.
Intervention Type
Drug
Intervention Name(s)
Systane - Autologous serum
Intervention Description
Systane (r) four times a day for two weeks. Then 0.9% sodium chloride used four times a day for one weeks. Finally, 20% autologous serum solution four times a day for two week.
Primary Outcome Measure Information:
Title
To compare the score reduction in the Ocular Surface Disease Index (OSDI) between patients treated with autologous serum and conventional artificial tears.
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
To compare variations in objective eye measurements, such as Tear Break Up Time and corneal-conjunctival staining according to the Oxford Score, in patients treated with autologous serum and conventional artificial tears.
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 years Severe Dry Eye, as defined by a OSDI score > or = 40 Plus: Tear Break Up Time (TBUT) < 5 seconds Cornea-conjunctival epithelial defects measured by Fluorescein staining and evaluation using the Oxford score. Exclusion Criteria: No dry eye associated ocular disease Unable to comply protocol Severe anemia Previous use of autologous serum Concomitant use of other topical ocular drug Hypersensibility to any proposed interventions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristhian A Urzua, MD
Organizational Affiliation
University of Chile
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Of Chile Clinical Hospital
City
Santiago
State/Province
Region Metropolitana
Country
Chile

12. IPD Sharing Statement

Citations:
PubMed Identifier
22670856
Citation
Urzua CA, Vasquez DH, Huidobro A, Hernandez H, Alfaro J. Randomized double-blind clinical trial of autologous serum versus artificial tears in dry eye syndrome. Curr Eye Res. 2012 Aug;37(8):684-8. doi: 10.3109/02713683.2012.674609. Epub 2012 Jun 6.
Results Reference
derived

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Autologous Serum Efficacy Study in Patients With Severe Dry Eye

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