Autologous Serum Efficacy Study in Patients With Severe Dry Eye - Full Text View

Sponsored by:	University of Chile
Information provided by:	University of Chile
ClinicalTrials.gov Identifier:	NCT00779987

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 II

Drug Information available for: Sodium chloride Chlorides

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study
Official Title:	Autologous Serum Efficacy Study in Patients With Severe Dry Eye

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, Region Metropolitana
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

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

Keywords provided by University of Chile:

Dry eye
Autologous serum
Ocular Surface Disease Index

ClinicalTrials.gov processed this record on January 14, 2009