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

Primary Purpose

Xerophthalmia

Status

Completed

Phase

Phase 1

Locations

Singapore

Study Type

Interventional

Intervention

Autologous serum eyedrops

About this trial

This is an interventional treatment trial for Xerophthalmia

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Singapore National Eye Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Serum eye drops

Arm Description

Patient's autologous serum is diluted in saline solution

Outcomes

Primary Outcome Measures

Staining

Grading of punctate corneal staining in the worse eye (second visit relative to first visit)

Secondary Outcome Measures

Symptoms

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

Schirmers test result

Tear-proteins

Tear protein analysis

Tear-stability

Tear break up time

Cornea

other corneal findings such as scarring, vascularisation, filaments etc

Conjunctiva

Documentation of conjunctival hyperemia, chemosis, scarring

Full Information

NCT ID

NCT01089985

First Posted

March 16, 2010

Last Updated

January 15, 2012

Sponsor

Singapore National Eye Centre

1. Study Identification

Unique Protocol Identification Number

NCT01089985

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Completed

Study Start Date

July 2010 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Singapore National Eye Centre

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Xerophthalmia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Serum eye drops

Arm Type

Experimental

Arm Description

Patient's autologous serum is diluted in saline solution

Intervention Type

Drug

Intervention Name(s)

Autologous serum eyedrops

Intervention Description

3 times a day for the duration of the study

Primary Outcome Measure Information:

Title

Staining

Description

Grading of punctate corneal staining in the worse eye (second visit relative to first visit)

Time Frame

4 months

Secondary Outcome Measure Information:

Title

Symptoms

Description

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 .

Time Frame

4 months

Title

Tear-production

Description

Schirmers test result

Time Frame

4 months

Title

Tear-proteins

Description

Tear protein analysis

Time Frame

4 months

Title

Tear-stability

Description

Tear break up time

Time Frame

4 months

Title

Cornea

Description

other corneal findings such as scarring, vascularisation, filaments etc

Time Frame

4 months

Title

Conjunctiva

Description

Documentation of conjunctival hyperemia, chemosis, scarring

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials: