Use of Autologous Serum Eye-drops as Tears in Patients With Recalcitrant Dry Eye

Study Overview
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Brief Summary
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The purpose of this study is to examine the efficacy and safety of autologous serum eye drops in people with recalcitrant dry eye.

Detailed Description
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A group of selected dry eye patients from the Singapore National Eye Centre who have exhausted the usual treatment options (lubricants, topical immunosuppressive and punctal occlusion) and not keen for tarsorrhaphy will be recruited. After informed consent, they will undergo plasmapheresis and start on daily autologous serum eyedrops for a period of 4 months. Clinical monitoring for standard dry eye parameters such as punctate corneal keratitis, Schirmers testing, tear break up time as well as severity and frequency of dry eye symptoms will be conducted. Tear inflammatory proteins captured on Schirmers paper pre and post treatment will be analysed as well.

Official Title
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Use of Autologous Serum Eye-drops as Tears in Patients With Recalcitrant Dry Eye

Conditions
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Xerophthalmia

Intervention / Treatment
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* Drug: Autologous serum eyedrops


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Seen at the dry eye service at the Singapore National Eye Centre Age between 21 and 75 years old Symptomatic for dry eye or VA worse than 6/12 in Snellen chart Presence of corneal punctate staining involving central zone Exhausted what is considered as standard therapy or therapy that is acceptable to the patient and the physician No contraindication for blood extraction/plasmapheresis Exclusion Criteria: HIV/HCV/HBV/syphilis

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Serum eye drops<br>Patient's autologous serum is diluted in saline solution | Drug: Autologous serum eyedrops<br>* 3 times a day for the duration of the study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Staining | Grading of punctate corneal staining in the worse eye (second visit relative to first visit) | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms | The change in Visual Analog Score (Schaumberg D et al Ocular Surface 2009). The global score is calculated from 2 scores, the frequency and severity of dry eye symptoms. From . | 4 months | 
| Tear-production | Schirmers test result | 4 months | 
| Tear-proteins | Tear protein analysis | 4 months | 
| Tear-stability | Tear break up time | 4 months | 
| Cornea | other corneal findings such as scarring, vascularisation, filaments etc | 4 months | 
| Conjunctiva | Documentation of conjunctival hyperemia, chemosis, scarring | 4 months |