Meibomian Gland DysfunctionNCT02943382
Fingerprick Autologous Blood (FAB) in Mebomian Gland Dysfunction (MGD)
A study testing Fingerprick autologous blood (FAB) in people with Meibomian Gland Dysfunction and Dry Eye Disease, run by Bedford Hospital NHS Trust.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meibomian Gland Dysfunction, Dry Eye Disease
- What is being tested?
- Fingerprick autologous blood (FAB)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- Pregnant or breast feeding women
- Fear of needles and unwillingness to carry out repeated finger pricks
- Past or current ocular malignancy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Use of Fingerprick Autologous Blood (FAB) in the Treatment of Mebomian Gland Dysfunction (MGD)
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.
Read the detailed 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.
- Conditions
- Meibomian Gland Dysfunction, Dry Eye Disease
- Being tested
- Fingerprick autologous blood (FAB)
- Keywords
- MGD, Autologous Serum, Meibomian gland dysfunction, Dry eye disease, FAB, Fingerprick autologous blood
- Medical subject headings
- Meibomian Gland Dysfunction, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fingerprick autologous blood (FAB)Other
Pricking of cleaned finger using diabetic lancet and applying blood droplet to affected eye. Repeated with separate finger for other affected eye.
| Study group | Role | What they receive |
|---|---|---|
| Fingerprick Autologous Blood (FAB) | Experimental | Assigned treatment with FAB Receives: Other: Fingerprick autologous blood (FAB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in clinical symptoms assessed using the OSDI questionnaire
Ocular surface disease index questionnaire (OSDI)
Measured: 2 months
Secondary outcomes (1)
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)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meibomian Gland DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bedford Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02943382
- Sponsor's protocol ID
- 473/2016/301
- Status last verified
- Oct 2016
- First submitted
- 12 Aug 2016
- Last updated
- 24 Oct 2016
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Fingerprick Autologous Blood (FAB) in the Treatment of Mebomian Gland Dysfunction (MGD)
- ClinicalTrials.gov ID
- NCT02943382
- Acronym / sponsor ID
- 473/2016/301
- Conditions
- Meibomian Gland Dysfunction, Dry Eye Disease
- Keywords
- MGD, Autologous Serum, Meibomian gland dysfunction, Dry eye disease, FAB, Fingerprick autologous blood
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Bedford Hospital NHS TrustUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 24 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fingerprick Autologous Blood (FAB) | Experimental | Other: Fingerprick autologous blood (FAB)Assigned treatment with FAB |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Fingerprick Autologous Blood (FAB) |
Primary outcome
Improvement in clinical symptoms assessed using the OSDI questionnaire
Time frame: 2 months
Ocular surface disease index questionnaire (OSDI)
1 secondary outcome
Improvement of Meibomian Gland Dysfunction signs assessed using the International Workshop on Meibomian Gland Dysfunction report on grading criteria
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Fingerprick autologous blood (FAB) in people with Meibomian Gland Dysfunction and Dry Eye Disease, run by Bedford Hospital NHS Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anant Sharma, MD (01234, anant.sharma@bedfordhospital.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in clinical symptoms assessed using the OSDI questionnaire (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2016.