Autologous Serum Efficacy Study in Patients With Severe Dry Eye

University of Chile

Status and phase: Completed; Phase 2

Conditions: Dry Eye

Treatments: Drug: Autologous serum - Systane; Drug: Systane - Autologous serum

Study type: Interventional

Funder types: Other

Identifiers

NCT00779987

AP261

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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12 participants in 2 patient groups

Autologous serum -Systane

Other group

Description:

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)

Treatment:

Drug: Autologous serum - Systane

Systane- Autologous serum

Other group

Description:

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.

Treatment:

Drug: Systane - Autologous serum