Fingerprick Autologous Blood (FAB) in Mebomian Gland Dysfunction (MGD)

Dry Eye Disease Clinical Trial

Official title:

The Use of Fingerprick Autologous Blood (FAB) in the Treatment of Mebomian Gland Dysfunction (MGD)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02943382
• Other study ID #: 473/2016/301
• Status: Not yet recruiting
• Phase: N/A
• First received: August 12, 2016
• Last updated: October 21, 2016
• Start date: November 2016
• Est. completion date: September 2019

Study information

• Verified date: October 2016
• Source: Bedford Hospital NHS Trust
• Contact: Anant Sharma, MD
• Phone: 01234
• Email: anant.sharma[@]bedfordhospital.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Health Research Authority
• Study type: Interventional

Clinical Trial Summary

Dry eye disease remains one of the most common complaints seen in ophthalmic clinics. Causes of dry eye are multifactorial, with the most common cause of evaporative dry eye disease being meibomian gland dysfunction (MGD).

Fingerprick autologous blood (FAB) is a novel method which uses a patient's own blood to treat dry eye conditions.

Description:

Dry eye disease remains one of the most common complaints seen in ophthalmic clinics, with one in four patients reporting symptoms of the condition (including soreness, foreign body sensation or temporary blurring of vision). Causes of dry eye are multifactorial, with the most common cause of evaporative dry eye disease being meibomian gland dysfunction (MGD).

A chronic, abnormality of the glands lining the eyelid. MGD results in alteration of the tear film, symptoms of eye irritation, inflammation and ocular surface disease. In those with moderate or severe disease (as defined by symptoms, clinical signs and corneal staining), anti-inflammatory therapy is recommended, with topical steroids or oral tetracyclines. However, both these treatments are accompanied by side effects; topical steroids cause increased intraocular pressure, and predispose to eye infection and cataracts, whilst tetracyclines cause skin phototoxicity.

Autologous serum drops are used as a treatment for severe dry eyes by providing growth factors and anti-inflammatory mediators to the ocular surface. It is derived from the liquid component of blood, after clotting factors and blood cells have been extracted. Obtaining this carries its own problems: numerous venesections from the patient, fridge storage to prevent bacterial contamination, and individual funding request as it is expensive.

The growth factors and anti-inflammatory mediators in serum are also present in whole blood; which can be obtained using a finger prick technique as in diabetics, thus bypassing the cost and storage problems associated with autologous serum.

Finger prick autologous blood (FAB) has shown efficacy and safety in the treatment of severe dry eye syndrome patients and persistent corneal epithelial defects. In this study, the investigators aim to find out whether FAB is an effective alternative to long-term anti-inflammatories in the treatment of MGD. Patient's with MGD will be recruited from Moorfields Eye clinic at Bedford Hospital. The study will be conducted over 2 years.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who have been diagnosed with meibomian gland dysfunction (based upon lid margin signs and consequent dry eye syndrome) with discomfort which affects their daily life, and who want further treatment and remain symptomatic despite optimum treatment (lid hygiene and massage, tried or are on artificial lubricants at least four times a day and tried or are on oral omega-3 oils).

Exclusion Criteria:

• Patients who do not have capacity to consent • Children (under 18 years old)

• Infected finger or systemic infection or on systemic antibiotics for infection

• Patients with immunodeficiency

• Infected finger or systemic infection or on systemic antibiotics for infection.

• 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

• Fear of needles and unwillingness to carry out repeated finger pricks

• Past or current ocular malignancy

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Disease
• Eye Diseases
• Meibomian Gland Dysfunction

Intervention

Other:
• Fingerprick autologous blood (FAB)
Pricking of cleaned finger using diabetic lancet and applying blood droplet to affected eye. Repeated with separate finger for other affected eye.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bedford Hospital NHS Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in clinical symptoms assessed using the OSDI questionnaire	Ocular surface disease index questionnaire (OSDI)	2 months	No
Secondary	Improvement of Meibomian Gland Dysfunction signs assessed using the International Workshop on Meibomian Gland Dysfunction report on grading criteria	To improve signs (grading of MGD) as per 'The International Workshop on Meibomian Gland Dysfunction' report on grading criteria (Tomlinson, 2011)	2 months	No