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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Louis Tong, Singapore National Eye Centre
ClinicalTrials.gov Identifier:
NCT01089985
First received: March 16, 2010
Last updated: January 15, 2012
Last verified: January 2012
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Singapore National Eye Centre:

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


Secondary Outcome Measures:
  • Symptoms [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    Schirmers test result

  • Tear-proteins [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    Tear protein analysis

  • Tear-stability [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    Tear break up time

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

  • Conjunctiva [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    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.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01089985

Locations
Singapore
Singapore National Eye Centre
Singapore, Singapore, 168571
Sponsors and Collaborators
Singapore National Eye Centre
Investigators
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

No publications provided

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

Additional relevant MeSH terms:
Xerophthalmia
Conjunctival Diseases
Eye Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Tetrahydrozoline
Ophthalmic Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 11, 2014