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

This study has been completed.
Information provided by (Responsible Party):
Louis Tong, Singapore National Eye Centre Identifier:
First received: March 16, 2010
Last updated: January 15, 2012
Last verified: January 2012
The purpose of this study is to examine the efficacy and safety of autologous serum eye drops in people with recalcitrant dry eye.

Condition Intervention Phase
Xerophthalmia Drug: Autologous serum eyedrops Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Autologous Serum Eye-drops as Tears in Patients With Recalcitrant Dry Eye

Resource links provided by NLM:

Further study details as provided by Louis Tong, Singapore National Eye Centre:

Primary Outcome Measures:
  • Staining [ Time Frame: 4 months ]
    Grading of punctate corneal staining in the worse eye (second visit relative to first visit)

Secondary Outcome Measures:
  • Symptoms [ Time Frame: 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-production [ Time Frame: 4 months ]
    Schirmers test result

  • Tear-proteins [ Time Frame: 4 months ]
    Tear protein analysis

  • Tear-stability [ Time Frame: 4 months ]
    Tear break up time

  • Cornea [ Time Frame: 4 months ]
    other corneal findings such as scarring, vascularisation, filaments etc

  • Conjunctiva [ Time Frame: 4 months ]
    Documentation of conjunctival hyperemia, chemosis, scarring

Enrollment: 10
Study Start Date: July 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Serum eye drops
Patient's autologous serum is diluted in saline solution
Drug: Autologous serum eyedrops
3 times a day for the duration of the study

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.

Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01089985

Singapore National Eye Centre
Singapore, Singapore, 168571
Sponsors and Collaborators
Singapore National Eye Centre
Principal Investigator: Louis Tong, FRCS, MD Singapore National Eye Centre
Principal Investigator: Ronald Chung Singapore National Eye Centre
Study Director: Roger Beuerman Singapore Eye Research Institute
Study Chair: Mickey Koh Singapore General Hospital
Study Chair: Samanthila Waduthantri Singapore National Eye Centre
Study Chair: Heng Joo Ng Singapore General Hospital
Study Chair: Rohani Salleh Singapore General Hospital
  More Information

Responsible Party: Louis Tong, Clinician-Scientist, Singapore National Eye Centre Identifier: NCT01089985     History of Changes
Other Study ID Numbers: R724/08/2010
Study First Received: March 16, 2010
Last Updated: January 15, 2012

Additional relevant MeSH terms:
Conjunctival Diseases
Eye Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents processed this record on September 25, 2017