NCT02153515

Brief Summary

To investigate if fresh finger prick autologous blood (FAB) instead of serum from venesection, is a safe and effective treatment for dry eyes and corneal ulcers/ epithelial defects. Currently there are no studies on the use of whole fresh blood for the treatment of chronic ulcers, persistent epithelial defects or dry eyes. Unpublished case reports indicate that fresh blood can be an effective tool to the treatment of corneal pathology.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2014

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 2, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 3, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

October 13, 2016

Status Verified

October 1, 2016

Enrollment Period

3.3 years

First QC Date

May 2, 2014

Last Update Submit

October 12, 2016

Conditions

Dry EyesSjogren's Disease With Dry EyesPersistent Corneal Epithelial DefectsChronic Corneal Ulcers

Keywords

Finger prick with diabetic lancetFingerprickFreshYour own bloodautologous bloodDry eyesSjogren's disease with dry eyesPersistent corneal epithelial defectsChronic corneal ulcers

Outcome Measures

Primary Outcomes (1)

  • Corneal ulcers / epithelial defects: Ulcers to heal within 4 weeks. Dry eyes: To improve signs (corneal and conjunctival staining, Schirmer's test, tear break up time ) or symptoms ( ocular comfort index questionnaire)

    Follow ups are 3 days, 2 weeks , 4 weeks and 2 months after commencing treatment. Then again 1 month after stopping treatment. Criteria to stop treatment based on patient safety such as finger infection in protocol.

    One month for corneal ulcers. Dry eyes 2 months.

Study Arms (1)

Fingerprick of autologous blood (FAB)

EXPERIMENTAL

Fingerprick of autologous blood (FAB) four times a day for 2 months

Other: Your own ( autologous) finger prick of blood produced with a diabetic lancet

Interventions

Your own ( autologous) finger prick of blood produced with a diabetic lancetOTHER
Fingerprick of autologous blood (FAB)

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • For Dry Eyes
  • Patients with symptoms of dry eyes on at least QDS lubricants and who in addition:
  • Satisfy at least one of the following criteria:
  • Break up time (BUT) \<5 seconds and Schirmer's test without anaesthesia \<5 mm at 5 minutes OR presence of rose bengal /lissamine green or fluorescein staining of the ocular surface OR more than 80% score on OCI due to dry eyes (total score greater than or equal to 29/36)
  • All patients must have unsuccessfully tried cyclosporine ointment or eye drops and temporary or permanent plugs or been offered punctual plugs and refused.
  • For Corneal Ulceration
  • Patients with epithelial defects of at least 2 weeks duration where conventional therapy failed. (Conventional therapy includes \[if indicated\] lubricants, antibiotic ointment, steroids and therapeutic contact lens wear)
  • Any patient with an epithelial defect of at least 4 weeks' duration that has not completely healed with conventional therapy or who are refusing further conventional therapy. These patients would receive FAB therapy instead of tarsorrhaphy or botulinum toxin induced ptosis.

You may not qualify if:

  • Fear of needles and unwillingness to carry out repeat finger pricks
  • Infected finger or systemic infection or on systemic antibiotics for infection.
  • Bleeding disorders and on warfarin anticoagulant therapy
  • Epithelial defect was classified as a progressive corneal melt caused by an immunological process such as rheumatoid melt or Mooren's ulceration.
  • Patients with active microbial infection, acute herpes simplex or herpes zoster keratitis, drug toxicity, vitamin A deficiency, or recurrent corneal erosion.
  • Past Ophthalmic history of corneal transplantation.
  • Pregnant or breast feeding women
  • Children (under 16 years old).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moorfields Eye Centre at Bedford Hospital NHS Trust

Bedford, Bedfordshire, MK42 9DJ, United Kingdom

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Anant Sharma, FRCOphth

    Moorfields Eye Hospital NHS Trust and Bedford Hospital NHS Trust

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2014

First Posted

June 3, 2014

Study Start

April 1, 2014

Primary Completion

August 1, 2017

Study Completion

November 1, 2017

Last Updated

October 13, 2016

Record last verified: 2016-10

Locations

GB(1)