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

S

Singapore National Eye Centre

Status and phase

Completed
Phase 1

Conditions

Xerophthalmia

Treatments

Drug: Autologous serum eyedrops

Study type

Interventional

Funder types

Other

Identifiers

NCT01089985
R724/08/2010

Details and patient eligibility

About

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

Full 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.

Enrollment

10 patients

Sex

All

Ages

21 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Serum eye drops
Experimental group
Description:
Patient's autologous serum is diluted in saline solution
Treatment:
Drug: Autologous serum eyedrops

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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