Autologous Serum Efficacy Study in Patients With Severe Dry Eye

Sponsor

University of Chile (Other)

Overall Status

Completed

CT.gov ID

NCT00779987

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Drug: Autologous serum - Systane Drug: Systane - Autologous serum	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Autologous Serum Efficacy Study in Patients With Severe Dry Eye

Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Other: 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)	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.
Other: 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.	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.

Arm

Intervention/Treatment

Other: 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)

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.

Other: 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.

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.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Of Chile Clinical Hospital	Santiago	Region Metropolitana	Chile

Sponsors and Collaborators

University of Chile

Investigators

Principal Investigator: Cristhian A Urzua, MD, University of Chile

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00779987

Other Study ID Numbers:

AP261

First Posted:

Oct 24, 2008

Last Update Posted:

Dec 3, 2008

Last Verified:

Oct 1, 2008

Keywords provided by , ,

Dry eye

Autologous serum

Ocular Surface Disease Index

Additional relevant MeSH terms:

Dry Eye Syndromes

Keratoconjunctivitis Sicca

Study Results

No Results Posted as of Dec 3, 2008