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Autologous Serum Efficacy Study in Patients With Severe Dry Eye

NCT ID: NCT00779987

Last Updated: 2008-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2008-12-31

Brief Summary

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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

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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.

Conditions

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Dry Eye

Keywords

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Dry eye Autologous serum Ocular Surface Disease Index

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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)

Group Type OTHER

Autologous serum - Systane

Intervention Type DRUG

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.

Group Type OTHER

Systane - Autologous serum

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Chile

OTHER

Sponsor Role lead

Responsible Party

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University of Chile

Principal Investigators

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Cristhian A Urzua, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chile

Locations

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University Of Chile Clinical Hospital

Santiago, Santiago Metropolitan, Chile

Site Status

Countries

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Chile

References

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Urzua CA, Vasquez DH, Huidobro A, Hernandez H, Alfaro J. Randomized double-blind clinical trial of autologous serum versus artificial tears in dry eye syndrome. Curr Eye Res. 2012 Aug;37(8):684-8. doi: 10.3109/02713683.2012.674609. Epub 2012 Jun 6.

Reference Type DERIVED
PMID: 22670856 (View on PubMed)

Other Identifiers

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AP261

Identifier Type: -

Identifier Source: org_study_id