Autologous Serum Efficacy Study in Patients With Severe Dry Eye

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00779987

Enrollment

Registered

2008-10-24

Start date

2008-10-31

Completion date

2008-12-31

Last updated

2008-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye

Keywords

Dry eye, Autologous serum, Ocular Surface Disease Index

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.

Interventions

DRUGAutologous 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.

DRUGSystane - 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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026