NCT01089985

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 19, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 18, 2012

Status Verified

January 1, 2012

Enrollment Period

1.4 years

First QC Date

March 16, 2010

Last Update Submit

January 15, 2012

Conditions

Xerophthalmia

Outcome Measures

Primary Outcomes (1)

  • Staining

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

    4 months

Secondary Outcomes (6)

  • Symptoms

    4 months

  • Tear-production

    4 months

  • Tear-proteins

    4 months

  • Tear-stability

    4 months

  • Cornea

    4 months

  • +1 more secondary outcomes

Study Arms (1)

Serum eye drops

EXPERIMENTAL

Patient's autologous serum is diluted in saline solution

Drug: Autologous serum eyedrops

Interventions

Autologous serum eyedropsDRUG

3 times a day for the duration of the study

Serum eye drops

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • HIV/HCV/HBV/syphilis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore National Eye Centre

Singapore, Singapore, 168571, Singapore

Location

MeSH Terms

Conditions

Xerophthalmia

Condition Hierarchy (Ancestors)

Conjunctival DiseasesEye DiseasesDry Eye SyndromesLacrimal Apparatus Diseases

Study Officials

  • Louis Tong, FRCS, MD

    Singapore National Eye Centre

    PRINCIPAL INVESTIGATOR

  • Ronald Chung

    Singapore National Eye Centre

    PRINCIPAL INVESTIGATOR

  • Roger Beuerman

    Singapore Eye Research Institute

    STUDY DIRECTOR

  • 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 CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinician-Scientist

Study Record Dates

First Submitted

March 16, 2010

First Posted

March 19, 2010

Study Start

July 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

January 18, 2012

Record last verified: 2012-01

Locations

SG(1)