Autologous Serum Efficacy Study in Patients With Severe Dry Eye

Dry Eye Clinical Trial

Official title:

Autologous Serum Efficacy Study in Patients With Severe Dry Eye

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00779987
• Other study ID #: AP261
• Status: Completed
• Phase: Phase 2
• First received: October 22, 2008
• Last updated: December 2, 2008
• Start date: October 2008
• Est. completion date: December 2008

Study information

• Verified date: October 2008
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

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
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.

Locations

Country	Name	City	State
Chile	University Of Chile Clinical Hospital	Santiago	Region Metropolitana

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the score reduction in the Ocular Surface Disease Index (OSDI) between patients treated with autologous serum and conventional artificial tears.		5 weeks	No
Secondary	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.		5 weeks	No