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Autologous Serum Efficacy Study in Patients With Severe Dry Eye

This study has been completed.
Sponsor:
Information provided by:
University of Chile
ClinicalTrials.gov Identifier:
NCT00779987
First received: October 22, 2008
Last updated: December 2, 2008
Last verified: October 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Dry Eye
 Drug: Autologous serum - Systane
Drug: Systane - Autologous serum
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Autologous Serum Efficacy Study in Patients With Severe Dry Eye

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Chile:

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. [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

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. [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: October 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Autologous serum -Systane
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)
 Drug: Autologous serum - Systane
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.
Systane- Autologous serum
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.
 Drug: Systane - Autologous serum
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00779987

Locations
Chile
University Of Chile Clinical Hospital
Santiago, Region Metropolitana, Chile
Sponsors and Collaborators
University of Chile
Investigators
Principal Investigator: Cristhian A Urzua, MD University of Chile
  More Information

No publications provided

Responsible Party: Cristhian A Urzua, University of Chile
ClinicalTrials.gov Identifier: NCT00779987     History of Changes
Other Study ID Numbers: AP261
Study First Received: October 22, 2008
Last Updated: December 2, 2008
Health Authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica

Keywords provided by University of Chile:
Dry eye
Autologous serum
Ocular Surface Disease Index

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
 Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on May 19, 2013