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Completed

NCT Number: NCT00779987

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.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Of Chile Clinical Hospital

Santiago, Santiago Metropolitan, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous serum - Systane

Drug

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

Drug

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 outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Oct 24, 2008
Registry last updated
Dec 3, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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