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

Phase 1

Completed

• Conditions: Xerophthalmia
• Interventions: Drug: Autologous serum eyedrops

• Registration Number: NCT01089985
• Lead Sponsor: Singapore National Eye Centre

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2010-03-16
• Study First Submitted QC: 2010-03-18
• Study First Posted: 2010-03-19
• Study Start: 2010-07
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-15
• Last Update Posted: 2012-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Serum eye drops	Autologous serum eyedrops	Patient's autologous serum is diluted in saline solution

Primary Outcome Measures

Name	Time	Method
Staining	4 months	Grading of punctate corneal staining in the worse eye (second visit relative to first visit)

Secondary Outcome Measures

Name	Time	Method
Conjunctiva	4 months	Documentation of conjunctival hyperemia, chemosis, scarring
Tear-production	4 months	Schirmers test result
Tear-stability	4 months	Tear break up time
Symptoms	4 months	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 .
Tear-proteins	4 months	Tear protein analysis
Cornea	4 months	other corneal findings such as scarring, vascularisation, filaments etc

Trial Locations

Locations (1)

Singapore National Eye Centre; 🇸🇬 Singapore, Singapore