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

October 22, 2008
December 2, 2008
October 2008
December 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00779987 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Autologous Serum Efficacy Study in Patients With Severe Dry Eye
Autologous Serum Efficacy Study in Patients With Severe Dry Eye

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Dry Eye
  • 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.
  • 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.
  • 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)
    Intervention: Drug: Autologous serum - Systane
  • 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.
    Intervention: Drug: Systane - Autologous serum
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Chile
 
NCT00779987
AP261
Yes
Cristhian A Urzua, University of Chile
University of Chile
Not Provided
Principal Investigator: Cristhian A Urzua, MD University of Chile
University of Chile
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP