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

January 15, 2012 updated by: Louis Tong, Singapore National Eye Centre
The purpose of this study is to examine the efficacy and safety of autologous serum eye drops in people with recalcitrant dry eye.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 168571
        • Singapore National Eye Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Staining
Time Frame: 4 months
Grading of punctate corneal staining in the worse eye (second visit relative to first visit)
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 .
4 months
Tear-production
Time Frame: 4 months
Schirmers test result
4 months
Tear-proteins
Time Frame: 4 months
Tear protein analysis
4 months
Tear-stability
Time Frame: 4 months
Tear break up time
4 months
Cornea
Time Frame: 4 months
other corneal findings such as scarring, vascularisation, filaments etc
4 months
Conjunctiva
Time Frame: 4 months
Documentation of conjunctival hyperemia, chemosis, scarring
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

March 16, 2010

First Submitted That Met QC Criteria

March 18, 2010

First Posted (Estimate)

March 19, 2010

Study Record Updates

Last Update Posted (Estimate)

January 18, 2012

Last Update Submitted That Met QC Criteria

January 15, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R724/08/2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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