Fingerprick Autologous Blood (FAB) in Severe Dry Eye Disease (DED) (FAB)

The Feasibility of Fingerprick Autologous Blood (FAB) As a Novel Treatment for Severe Dry Eye Disease (DED)

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.

Study Overview

• Status: Unknown
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Other: Fingerprick autologuos blood (FAB)

Detailed Description

Autologous serum (AS) eye drops have been found in uncontrolled trials to be beneficial in DED patient by improving the ocular surface and reducing symptoms. Obtaining autologous serum requires frequent drawing of blood from the patient- a feature that excludes patients with anaemia or heart failure from using AS. Furthermore it also appears that 100% autologous serum is more beneficial than 50% serum and requires larger volumes of blood and/or more frequent venesection. Patients using AS also require access to a fridge as the product needs to be stored at low temperatures; a factor that is likely to be inconvenient for patients. In addition, AS is obtained by processing clotted blood which is often too expensive for the health service to consistently purchase, given the initial cost of £1653.56 and subsequent three-monthly cost of £1131.27 per patient.

The relatively high cost represents the biggest hurdle in the use of AS and is often the reason for delay or inaccessibility in starting treatment for DED using AS. However, we propose that finger prick autologous blood may be a simpler, cost-effective and possibly more acceptable method for treating dry eye disease. For this reason, 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.

The proposing team have completed an exploratory study on the use of finger-prick autologous blood (FAB) for persistent epithelial defects and severe dry eye disease and preliminary results indicate improvement with no adverse events reported. The exploratory study included 16 patients with a diagnosis of severe to moderate dry eye syndrome and used the FAB method for treatment. The findings of the study demonstrated mean improvements in visual acuity, Oxford corneal staining grade, tear breakup time, Schirmer's test and dry eye disease questionnaire score. The response rate from participants was good with only a single patient who met the inclusion criteria not wishing to participate in the trial on the advice of their general practitioner. Both the amount of staining (indicating inflammation and ocular surface damage) and their DED questionnaire scores (indicating severity of their symptoms and impact on quality of life) showed mean improvement which reached statistical significance.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: FAB group; 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); Intervention involves the instillation of whole blood obtained from the prick of a clean finger 4 times a day.; Other Names: FAB
NO_INTERVENTION: Control group; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in corneal inflammation as indicated by staining on front of the eye	Assessed using the Oxford Corneal Staining Guide graded on a scale from 0 to 5 in order of increasing severity	3 months
Patient pain and symptoms scores	This will be assessed by Ocular Surface Disease Index (OSDI) score assessed on a scale of 0 to 100 with higher score representing severity	3 months
Improvement in objective signs of dry eye disease as indicated by visual acuity	This will be assessed using the Snellen chart	3 months
Willingness for patients to be randomised and acceptability of the intervention	This will be assessed by structured qualitative interviews	3 months
Impact on patients' quality of life	This will be assessed by EQ-5D-5L score with higher scores indicating improvement in quality of life	3 months
Cost to the NHS and patient	This will be assessed by use of additional NHS services and privately purchased over the counter treatments related to dry eyes disease	3 months
Intraocular pressure (IOT)	Intraocular pressure will be measured to assessed safety of the intervention	3 months

Collaborators and Investigators

• Sponsor: Bedford Hospital NHS Trust
• Collaborators: Anglia Ruskin University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2018
• Primary Completion (ANTICIPATED): April 1, 2019
• Study Completion (ANTICIPATED): July 1, 2019

Study Registration Dates

• First Submitted: November 2, 2017
• First Submitted That Met QC Criteria: January 9, 2018
• First Posted (ACTUAL): January 10, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 10, 2018
• Last Update Submitted That Met QC Criteria: January 9, 2018
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Autologuous serum; dry eyes disease; fingerprick blood
• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: IRAS 233813

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No