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

NCT ID: NCT03395431

Last Updated: 2018-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-28
• Study Completion Date: 2019-07-31

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.

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.

Conditions

Dry Eye Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Fingerprick autologuos blood (FAB)

Intervention Type: OTHER

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

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Fingerprick autologuos blood (FAB)

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

Intervention Type: OTHER

Other Intervention Names

FAB

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anglia Ruskin University

OTHER

Sponsor Role: collaborator

Bedford Hospital NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Anant Sharma, MD

Role: CONTACT

anant.sharma@bedfordhospital.nhs.uk

01234

Shafi Balal, MBBS

Role: CONTACT

shafi.balal@nhs.net

01234

References

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.

Reference Type: BACKGROUND

PMID: 11567963 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10434857 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 6712760 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28622325 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30385451 (View on PubMed)

Other Identifiers

IRAS 233813

Identifier Type: -

Identifier Source: org_study_id