Autologous Serum Efficacy Study in Patients With Severe Dry Eye

This study has been completed.

Sponsor:

Information provided by:

University of Chile

ClinicalTrials.gov Identifier:

NCT00779987

First received: October 22, 2008

Last updated: December 2, 2008

Last verified: October 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

October 22, 2008

Last Updated Date

December 2, 2008

Start Date ^ICMJE

October 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To compare the score reduction in the Ocular Surface Disease Index (OSDI) between patients treated with autologous serum and conventional artificial tears. [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00779987 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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. [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Autologous Serum Efficacy Study in Patients With Severe Dry Eye

Official Title ^ICMJE

Autologous Serum Efficacy Study in Patients With Severe Dry Eye

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Dry Eye

Intervention ^ICMJE

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.
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.

Study Arm (s)

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)

Intervention: Drug: Autologous serum - Systane
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.

Intervention: Drug: Systane - Autologous serum

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Chile

Administrative Information

NCT Number ^ICMJE

NCT00779987

Other Study ID Numbers ^ICMJE

AP261

Has Data Monitoring Committee

Yes

Responsible Party

Cristhian A Urzua, University of Chile

Study Sponsor ^ICMJE

University of Chile

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Cristhian A Urzua, MD

University of Chile

Information Provided By

University of Chile

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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