Autologous Serum Efficacy Study in Patients With Severe Dry Eye

Phase 2

Completed

• Conditions: Dry Eye
• Interventions: Drug: Autologous serum - Systane; Drug: Systane - Autologous serum

• Registration Number: NCT00779987
• Lead Sponsor: University of Chile

Brief 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.

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.

Study Timeline

• Status Verified: 2008-10
• Study Start: 2008-10
• Study First Submitted: 2008-10-22
• Study First Submitted QC: 2008-10-22
• Study First Posted: 2008-10-24
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Last Update Submitted: 2008-12-02
• Last Update Posted: 2008-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Autologous serum -Systane	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)
Systane- Autologous serum	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.

Primary Outcome Measures

Name	Time	Method
To compare the score reduction in the Ocular Surface Disease Index (OSDI) between patients treated with autologous serum and conventional artificial tears.	5 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Of Chile Clinical Hospital; 🇨🇱 Santiago, Region Metropolitana, Chile