Autologous Serum Efficacy Study in Patients With Severe Dry Eye

Study Overview
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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.

Official Title
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Autologous Serum Efficacy Study in Patients With Severe Dry Eye

Conditions
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Dry Eye

Intervention / Treatment
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* Drug: Autologous serum - Systane
* Drug: Systane - Autologous serum


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Autologous serum -Systane<br>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<br>* 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.<br>|
| Other: Systane- Autologous serum<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autologous serum, Dry eye, Ocular Surface Disease Index