Dry Eye SyndromesFABNCT03395431
Fingerprick Autologous Blood (FAB) in Severe Dry Eye Disease (DED)
A study testing Fingerprick autologuos blood (FAB) in people with Dry Eye Syndromes, run by Bedford Hospital NHS Trust.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- Fingerprick autologuos blood (FAB)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Feb 2018to Jul 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
- 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
Who cannot join
- 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)
Show all 9Show fewer
- Systemic illness causing immune system deficiency
- Graft versus host disease
- Previous use of autologous serum within 3 months
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Being tested
- Fingerprick autologuos blood (FAB)
- Keywords
- Autologuous serum, dry eyes disease, fingerprick blood
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fingerprick autologuos blood (FAB)Other
Also called FAB
Intervention involves the instillation of whole blood obtained from the prick of a clean finger 4 times a day.
| Study group | Role | What they receive |
|---|---|---|
| FAB group | Active comparator | 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 Receives: Other: Fingerprick autologuos blood (FAB) |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Number of patients who adhere to trial protocol
Measured by self-reported adherence to trial protocol
Measured: 12months
Secondary outcomes (7)
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
Measured: 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
Measured: 3 months
Improvement in objective signs of dry eye disease as indicated by visual acuity
This will be assessed using the Snellen chart
Measured: 3 months
Willingness for patients to be randomised and acceptability of the intervention
This will be assessed by structured qualitative interviews
Measured: 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
Measured: 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
Measured: 3 months
Intraocular pressure (IOT)
Intraocular pressure will be measured to assessed safety of the intervention
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study startFeb 2018 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dry Eye SyndromesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single blind parallel group randomized control trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bedford Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Anglia Ruskin University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03395431
- Sponsor's protocol ID
- IRAS 233813
- Acronym
- FAB
- Status last verified
- Nov 2017
- First submitted
- 2 Nov 2017
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 11567963Tsubota 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.
PubMed 10434857Fox 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.
PubMed 6712760Than 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.
PubMed 28622325Balal 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.
PubMed 30385451
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Fingerprick Autologous Blood (FAB) As a Novel Treatment for Severe Dry Eye Disease (DED)
- ClinicalTrials.gov ID
- NCT03395431
- Acronym / sponsor ID
- FAB / IRAS 233813
- Conditions
- Dry Eye Syndromes
- Keywords
- Autologuous serum, dry eyes disease, fingerprick blood
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bedford Hospital NHS TrustUniversity, hospital or other
- Collaborators
- Anglia Ruskin University
- Study start
- Feb 2018 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 10 Jan 2018 (actual)
- 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 (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A single blind parallel group randomized control trial
| Arm | Type | Receives |
|---|---|---|
| FAB group | Active comparator | Other: Fingerprick autologuos blood (FAB)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 |
| Control group | No intervention | –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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 autologuos blood (FAB)Also: FABIntervention involves the instillation of whole blood obtained from the prick of a clean finger 4 times a day. | Other | FAB group |
Primary outcome
Number of patients recruited into the study within the specified time frame
Time frame: 12 months
This will involve specifically assessing the number of eligible patient in study population consented and randomized.
Number of patients who adhere to trial protocol
Time frame: 12months
Measured by self-reported adherence to trial protocol
7 secondary outcomes
Reduction in corneal inflammation as indicated by staining on front of the eye
Time frame: 3 months
Patient pain and symptoms scores
Time frame: 3 months
Improvement in objective signs of dry eye disease as indicated by visual acuity
Time frame: 3 months
Willingness for patients to be randomised and acceptability of the intervention
Time frame: 3 months
Impact on patients' quality of life
Time frame: 3 months
Cost to the NHS and patient
Time frame: 3 months
Intraocular pressure (IOT)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
- Background: PubMed 11567963Poon 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.
- Background: PubMed 10434857Tsubota 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.
- Background: PubMed 6712760Fox 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.
- Background: PubMed 28622325Than 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.
- Derived from this study: PubMed 30385451Balal 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.
- Individual participant dataSharing planned: No
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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 autologuos blood (FAB) in people with Dry Eye Syndromes, 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 5 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 10 Jan 2018. 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?
Number of patients recruited into the study within the specified time frame (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03395431, which also lists 5 linked publications.
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 10 Jan 2018.