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

Dry Eye Syndromes Clinical Trial

— FAB  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03395431
• Other study ID #: IRAS 233813
• Status: Not yet recruiting
• Phase: N/A
• First received: November 2, 2017
• Last updated: January 9, 2018
• Start date: February 2018
• Est. completion date: July 2019

Study information

• Verified date: November 2017
• Source: Bedford Hospital NHS Trust
• Contact: Anant Sharma, MD
• Phone: 01234
• Email: anant.sharma[@]bedfordhospital.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Other:
• Fingerprick autologuos blood (FAB)
Intervention involves the instillation of whole blood obtained from the prick of a clean finger 4 times a day.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bedford Hospital NHS Trust	Anglia Ruskin University

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

Tsubota K, Goto E, Fujita H, Ono M, Inoue H, Saito I, Shimmura S. Treatment of dry eye by autologous serum application in Sjögren's syndrome. Br J Ophthalmol. 1999 Apr;83(4):390-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of patients who adhere to trial protocol	Measured by self-reported adherence to trial protocol	12months
Secondary	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
Secondary	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
Secondary	Improvement in objective signs of dry eye disease as indicated by visual acuity	This will be assessed using the Snellen chart	3 months
Secondary	Willingness for patients to be randomised and acceptability of the intervention	This will be assessed by structured qualitative interviews	3 months
Secondary	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
Secondary	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
Secondary	Intraocular pressure (IOT)	Intraocular pressure will be measured to assessed safety of the intervention	3 months