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

Xerophthalmia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01089985
• Other study ID #: R724/08/2010
• Status: Completed
• Phase: Phase 1
• First received: March 16, 2010
• Last updated: January 15, 2012
• Start date: July 2010
• Est. completion date: December 2011

Study information

• Verified date: January 2012
• Source: Singapore National Eye Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Xerophthalmia

Intervention

Drug:
• Autologous serum eyedrops
3 times a day for the duration of the study

Locations

Country	Name	City	State
Singapore	Singapore National Eye Centre	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Singapore National Eye Centre

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Staining	Grading of punctate corneal staining in the worse eye (second visit relative to first visit)	4 months	Yes
Secondary	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	Yes
Secondary	Tear-production	Schirmers test result	4 months	Yes
Secondary	Tear-proteins	Tear protein analysis	4 months	Yes
Secondary	Tear-stability	Tear break up time	4 months	Yes
Secondary	Cornea	other corneal findings such as scarring, vascularisation, filaments etc	4 months	Yes
Secondary	Conjunctiva	Documentation of conjunctival hyperemia, chemosis, scarring	4 months	Yes