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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01089985
Recruitment Status : Completed
First Posted : March 19, 2010
Last Update Posted : January 18, 2012
Sponsor:
Information provided by (Responsible Party):
Louis Tong, Singapore National Eye Centre

Study Description
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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.

Condition or disease Intervention/treatment Phase
Xerophthalmia Drug: Autologous serum eyedrops Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
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
Study Start Date : July 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arms and Interventions
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Arm Intervention/treatment
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


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


Secondary Outcome Measures :
  1. 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 .


  2. Tear-production [ Time Frame: 4 months ]
    Schirmers test result

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

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

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

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


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01089985


Locations
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Singapore
Singapore National Eye Centre
Singapore, Singapore, 168571
Sponsors and Collaborators
Singapore National Eye Centre
Investigators
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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
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Responsible Party: Louis Tong, Clinician-Scientist, Singapore National Eye Centre
ClinicalTrials.gov Identifier: NCT01089985    
Other Study ID Numbers: R724/08/2010
First Posted: March 19, 2010    Key Record Dates
Last Update Posted: January 18, 2012
Last Verified: January 2012
Additional relevant MeSH terms:
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Xerophthalmia
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
 Conjunctival Diseases
Ophthalmic Solutions
Pharmaceutical Solutions