NCT03395431

Brief Summary

Dry eye disease (DED) is an umbrella term encompassing a range of diseases estimated to affect 14% of all adults aged 48 to 91. If left untreated, DED can lead to severe reduction in the quality of life of the sufferer. It can also cause loss of vision, pain in response to light, painful recurring stabbing sensations, and the feeling of grit in the affected eye(s). No curative agents for DED exist. Available conventional treatment options for DED such as artificial tears often only alleviate symptoms, have limited effectiveness, and in most cases patients may fail to respond; although the exact rate of treatment failure is unavailable in the published literature. Crudely, human tears with its vast constituents is essentially filtered blood and as such is an obvious source for a "tear mimic" containing the substances of tears. Blood, and several blood derived products, including autologous serum, have been studied as tear substitute candidates. This study proposes to test the use of finger prick autologous blood (FAB) technique in which whole blood is applied to the eye from a cleaned finger.

Trial Health

35
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 P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Status
unknown

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

November 2, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 10, 2018

Completed
22 days until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

January 10, 2018

Status Verified

November 1, 2017

Enrollment Period

1.2 years

First QC Date

November 2, 2017

Last Update Submit

January 9, 2018

Conditions

Dry Eye Syndromes

Keywords

Autologuous serumdry eyes diseasefingerprick blood

Outcome Measures

Primary Outcomes (2)

  • Number of patients recruited into the study within the specified time frame

    This will involve specifically assessing the number of eligible patient in study population consented and randomized.

    12 months

  • Number of patients who adhere to trial protocol

    Measured by self-reported adherence to trial protocol

    12months

Secondary Outcomes (7)

  • Reduction in corneal inflammation as indicated by staining on front of the eye

    3 months

  • Patient pain and symptoms scores

    3 months

  • Improvement in objective signs of dry eye disease as indicated by visual acuity

    3 months

  • Willingness for patients to be randomised and acceptability of the intervention

    3 months

  • Impact on patients' quality of life

    3 months

  • +2 more secondary outcomes

Study Arms (2)

FAB group

ACTIVE COMPARATOR

Arm A - Finger prick autologous blood (FAB) plus conventional treatment The patients will use FAB alongside conventional therapy as recommended by their treating ophthalmologist. A fingertip of the hand will be wiped with an alcohol steret and self-pricked using a standard diabetic lancet. The drop of blood is produced as normal and applied to the lower fornix of the affected eye(s) with the lower lid pulled down slightly by the patient. The blood will be applied 4 times a day. A fresh finger should be used for each eye. FAB should be applied at least 15 minutes after any artificial tears and no other drops applied for at least half an hour afterwards

Other: Fingerprick autologuos blood (FAB)

Control group

NO INTERVENTION

Arm B - Conventional treatment only The patients will use conventional therapy (artificial tears, cyclosporin drops and punctal plugs/cautery) as recommended by their treating ophthalmologist

Interventions

Fingerprick autologuos blood (FAB)OTHER

Intervention involves the instillation of whole blood obtained from the prick of a clean finger 4 times a day.

Also known as: FAB
FAB group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient age ≥ 18 years
  • Severe symptomatic dry eye disease diagnosed by: Ocular surface disease index (OSDI) score of greater than 33; OR Oxford Corneal Staining grade 2 or greater; OR Schirmer's without anaesthesia \<5mm at 5 minutes
  • Patients on artificial tears and/or lubricating drops/gel two or more times a day
  • Patient able to give consent
  • Patients able and willing complete the quality of life (QoL) questionnaires required for the study

You may not qualify if:

  • Fear of needles
  • Unable or not willing to carry out repeat finger pricks
  • Patients with infected finger/s or systemic infection or on systemic antibiotics for infection.
  • Patients with active ocular infection, active immunological corneal melt, or recurrent corneal erosion.
  • Pregnant or breast feeding women
  • Previous use of FAB treatment (e.g. from exploratory study)
  • Systemic illness causing immune system deficiency
  • Graft versus host disease
  • Previous use of autologous serum within 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Poon AC, Geerling G, Dart JK, Fraenkel GE, Daniels JT. Autologous serum eyedrops for dry eyes and epithelial defects: clinical and in vitro toxicity studies. Br J Ophthalmol. 2001 Oct;85(10):1188-97. doi: 10.1136/bjo.85.10.1188.

    PMID: 11567963BACKGROUND

  • Tsubota K, Goto E, Fujita H, Ono M, Inoue H, Saito I, Shimmura S. Treatment of dry eye by autologous serum application in Sjogren's syndrome. Br J Ophthalmol. 1999 Apr;83(4):390-5. doi: 10.1136/bjo.83.4.390.

    PMID: 10434857BACKGROUND

  • Fox RI, Chan R, Michelson JB, Belmont JB, Michelson PE. Beneficial effect of artificial tears made with autologous serum in patients with keratoconjunctivitis sicca. Arthritis Rheum. 1984 Apr;27(4):459-61. doi: 10.1002/art.1780270415. No abstract available.

    PMID: 6712760BACKGROUND

  • Than J, Balal S, Wawrzynski J, Nesaratnam N, Saleh GM, Moore J, Patel A, Shah S, Sharma B, Kumar B, Smith J, Sharma A. Fingerprick autologous blood: a novel treatment for dry eye syndrome. Eye (Lond). 2017 Dec;31(12):1655-1663. doi: 10.1038/eye.2017.118. Epub 2017 Jun 16.

    PMID: 28622325BACKGROUND

  • Balal S, Udoh A, Pappas Y, Cook E, Barton G, Hassan A, Hayden K, Bourne RRA, Ahmad S, Pardhan S, Harrison M, Sharma B, Wasil M, Sharma A. The feasibility of finger prick autologous blood (FAB) as a novel treatment for severe dry eye disease (DED): protocol for a randomised controlled trial. BMJ Open. 2018 Oct 31;8(10):e026770. doi: 10.1136/bmjopen-2018-026770.

    PMID: 30385451DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Central Study Contacts

Anant Sharma, MD

CONTACT

01234anant.sharma@bedfordhospital.nhs.uk

Shafi Balal, MBBS

CONTACT

01234shafi.balal@nhs.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor will be blinded to group assignment
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A single blind parallel group randomized control trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2017

First Posted

January 10, 2018

Study Start

February 1, 2018

Primary Completion

April 1, 2019

Study Completion

July 1, 2019

Last Updated

January 10, 2018

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share