Dry EyesPhase 3FABNCT02153515
Treating Dry Eyes and Corneal Ulcers With Fingerprick Autologous Blood
A Phase 3 study testing Your own ( autologous) finger prick of blood produced with a diabetic lancet in people with Dry Eyes and Sjogren's Disease With Dry Eyes, run by Bedford Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
To investigate if fresh finger prick autologous blood (FAB) instead of serum from venesection, is a safe and effective treatment for dry eyes and corneal ulcers/ epithelial defects. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Dry Eyes, Sjogren's Disease With Dry Eyes, Persistent Corneal Epithelial Defects
- What is being tested?
- Your own ( autologous) finger prick of blood produced with a diabetic lancet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2014to Nov 2017
- Phase
- Phase 3
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- For Dry Eyes
- Patients with symptoms of dry eyes on at least QDS lubricants and who in addition:
- Satisfy at least one of the following criteria:
- Break up time (BUT) <5 seconds and Schirmer's test without anaesthesia <5 mm at 5 minutes OR presence of rose bengal /lissamine green or fluorescein staining of the ocular surface OR more than 80% score on OCI due to dry eyes (total score greater than or equal to 29/36)
- All patients must have unsuccessfully tried cyclosporine ointment or eye drops and temporary or permanent plugs or been offered punctual plugs and refused.
- For Corneal Ulceration
- Patients with epithelial defects of at least 2 weeks duration where conventional therapy failed. (Conventional therapy includes [if indicated] lubricants, antibiotic ointment, steroids and therapeutic contact lens wear)
- Any patient with an epithelial defect of at least 4 weeks' duration that has not completely healed with conventional therapy or who are refusing further conventional therapy. These patients would receive FAB therapy instead of tarsorrhaphy or botulinum toxin induced ptosis.
Who cannot join
- Fear of needles and unwillingness to carry out repeat finger pricks
- Infected finger or systemic infection or on systemic antibiotics for infection.
- Bleeding disorders and on warfarin anticoagulant therapy
- Epithelial defect was classified as a progressive corneal melt caused by an immunological process such as rheumatoid melt or Mooren's ulceration.
- 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
- Children (under 16 years old).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Moorfields Eye Centre at Bedford Hospital NHS Trust
Bedford, Bedfordshire, MK42 9DJ
About this study
Official title: Fingerprick Fresh Blood for Treatment of Chronic Corneal Ulcers, Persistent Epithelial Defects and Dry Eyes
To investigate if fresh finger prick autologous blood (FAB) instead of serum from venesection, is a safe and effective treatment for dry eyes and corneal ulcers/ epithelial defects. Currently there are no studies on the use of whole fresh blood for the treatment of chronic ulcers, persistent epithelial defects or dry eyes. Unpublished case reports indicate that fresh blood can be an effective tool to the treatment of corneal pathology.
Read the detailed description
Background Autologous serum is used for chronic ulcers and dry eyes. Currently there are no studies on the use of whole fresh blood for the treatment of chronic ulcers, persistent epithelial defects or dry eyes.
Dry eye syndrome (DES) refers to a common but highly heterogeneous group of ocular surface disorders with varying disease severity, due to lack of sufficient tears or sufficient quality of tears. Corneal and conjunctival studies, using a variety of definitions, have estimated the prevalence of ''significant'' DES to be about 10-20% in the adult population, although fortunately severe DES is less frequent (Hikichi et al., 1995; Bjerrum, 1997; Doughty et al., 1997; Bandeen-Roche et al., 1997; Caffery et al., 1998; McCarty et al., 1998; Schein et al., 1999; Moss et al., 2000; Begley et al., 2002; Chia et al., 2003; Lin et al., 2003; Schaumberg et al., 2003).
Dry eye is usually managed with conventional treatment of artificial tears, punctual plugs, occlusive goggles and bandage contact lenses. In spite of maximal conventional therapy, there is a cohort of patients who have persistent symptoms and signs. This represents a more serious ocular surface disorder with patients having significant visual impairment and disability. Particularly severe dry eye might be managed with contact lenses, botulinum toxin induced ptosis and surgical tarsorrhapy. These treatments are not without their own hazards such as infection from contact lenses, reduced vision from the ptosis or surgical tarsorrhapy, particularly in only seeing eyes.
Corneal ulcers are usually managed with artificial tears, antibiotic ointment, bandage contact lenses and steroids.
Autologous serum eye drops have been found in uncontrolled trials to be beneficial in these patients, improving the ocular surface and reducing symptoms (Poon et al., 2001; Fox et al., 1984; Tsubota et all, 1999;). In addition, impression cytology and in vitro toxicity testing demonstrated that serum drops have reduced toxicity compared with unpreserved hydroxypropylmethylcellulose (Noble et al., 2004; Poon et al., 2001)
Obtaining serum requires frequent venesection with significant amount of blood taken. It is also expensive. The serum is aliquoted into hundreds of bottles with the additional risk of bacterial contamination. It also requires a fridge and storage facilities for these aliquoted bottles at the patient's home. Because of these requirements some patients are excluded, for example patients with anaemia because they are unable to give blood. In addition, often there is a delay in starting the treatment for organizational and / or funding reasons that can be detrimental to the course of the disease, causing unnecessary surgery and corneal melt resulting in perforation with potential loss of the eye. The FAB method could be used immediately for patients who are awaiting conventional treatment for autologous blood. Furthermore it also appears that 100% autologous serum is more beneficial than 50% serum (Poon et al), thereby larger volumes of blood and/or more frequent venesection is required.
Autologous fresh blood is already used subconjunctivally to help heal leaking trabeculectomy blebs (Dinah et al.2010; Biswas et al. 2009; Burnstein et al. 2001; Haynes et al., 1999). Autologous blood is also used to help attach limbal autografts in cases of pterygium (de Wit et al. 2010) and in vitreoretinal macular hole surgery (Lai et al. 2009; Chuang et al. 2010; McCannel et al. 2008; Lai et al.,2005). No adverse effects have been reported in these studies. The object of this study is to investigate if serum via a drop of fresh blood is an effective treatment for dry eye and corneal ulcers which currently require venesected autologous blood and would be particularly useful in the current group of patients in whom venesection is contraindicated.
If shown to be effective this may replace current autologous serum practice and its ease of use and reduced cost may mean that it could be extended to other ocular surface diseases or moderate dry eyes and used earlier in corneal epithelial defects.
- Conditions
- Dry Eyes, Sjogren's Disease With Dry Eyes, Persistent Corneal Epithelial Defects, Chronic Corneal Ulcers
- Being tested
- Your own ( autologous) finger prick of blood produced with a diabetic lancet
- Keywords
- Finger prick with diabetic lancet, Fingerprick, Fresh, Your own blood, autologous blood, Dry eyes, Sjogren's disease with dry eyes, Persistent corneal epithelial defects, Chronic corneal ulcers
- 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.
Your own ( autologous) finger prick of blood produced with a diabetic lancetOther
| Study group | Role | What they receive |
|---|---|---|
| Fingerprick of autologous blood (FAB) | Experimental | Fingerprick of autologous blood (FAB) four times a day for 2 months Receives: Other: Your own ( autologous) finger prick of blood produced with a diabetic lancet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal ulcers / epithelial defects: Ulcers to heal within 4 weeks. Dry eyes: To improve signs (corneal and conjunctival staining, Schirmer's test, tear break up time ) or symptoms ( ocular comfort index questionnaire)
Follow ups are 3 days, 2 weeks , 4 weeks and 2 months after commencing treatment. Then again 1 month after stopping treatment.
Criteria to stop treatment based on patient safety such as finger infection in protocol.
Measured: One month for corneal ulcers. Dry eyes 2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startApr 2014
- Primary completionAug 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bedford Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Moorfields Eye Hospital NHS Foundation Trust, The Mater Infirmary Hospital Belfast, UK., Milton Keynes University Hospital NHS Foundation Trust, Heart of England NHS Trust, University Hospitals Bristol and Weston NHS Foundation Trust, Birmingham Midland Eye Centre
- Responsible party
- Sponsor
- Investigators
- Anant Sharma, FRCOphth, Study chair, Moorfields Eye Hospital NHS Trust and Bedford Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02153515
- Sponsor's protocol ID
- 426/2014/340
- Acronym
- FAB
- Status last verified
- Oct 2016
- First submitted
- 2 May 2014
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fingerprick Fresh Blood for Treatment of Chronic Corneal Ulcers, Persistent Epithelial Defects and Dry Eyes
- ClinicalTrials.gov ID
- NCT02153515
- Acronym / sponsor ID
- FAB / 426/2014/340
- Conditions
- Dry Eyes, Sjogren's Disease With Dry Eyes, Persistent Corneal Epithelial Defects, Chronic Corneal Ulcers
- Keywords
- Finger prick with diabetic lancet, Fingerprick, Fresh, Your own blood, autologous blood, Dry eyes, Sjogren's disease with dry eyes, Persistent corneal epithelial defects
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bedford Hospital NHS TrustUniversity, hospital or other
- Collaborators
- Moorfields Eye Hospital NHS Foundation Trust, The Mater Infirmary Hospital Belfast, UK., Milton Keynes University Hospital NHS Foundation Trust, Heart of England NHS Trust, University Hospitals Bristol and Weston NHS Foundation Trust, Birmingham Midland Eye Centre
- Study start
- Apr 2014
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 3 Jun 2014 (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.
To investigate if fresh finger prick autologous blood (FAB) instead of serum from venesection, is a safe and effective treatment for dry eyes and corneal ulcers/ epithelial defects. Currently there are no studies on the use of whole fresh blood for the treatment of chronic ulcers, persistent epithelial defects or dry eyes. Unpublished case reports indicate that fresh blood can be an effective tool to the treatment of corneal pathology.
Detailed description
Background Autologous serum is used for chronic ulcers and dry eyes. Currently there are no studies on the use of whole fresh blood for the treatment of chronic ulcers, persistent epithelial defects or dry eyes.
Dry eye syndrome (DES) refers to a common but highly heterogeneous group of ocular surface disorders with varying disease severity, due to lack of sufficient tears or sufficient quality of tears. Corneal and conjunctival studies, using a variety of definitions, have estimated the prevalence of ''significant'' DES to be about 10-20% in the adult population, although fortunately severe DES is less frequent (Hikichi et al., 1995; Bjerrum, 1997; Doughty et al., 1997; Bandeen-Roche et al., 1997; Caffery et al., 1998; McCarty et al., 1998; Schein et al., 1999; Moss et al., 2000; Begley et al., 2002; Chia et al., 2003; Lin et al., 2003; Schaumberg et al., 2003).
Dry eye is usually managed with conventional treatment of artificial tears, punctual plugs, occlusive goggles and bandage contact lenses. In spite of maximal conventional therapy, there is a cohort of patients who have persistent symptoms and signs. This represents a more serious ocular surface disorder with patients having significant visual impairment and disability. Particularly severe dry eye might be managed with contact lenses, botulinum toxin induced ptosis and surgical tarsorrhapy. These treatments are not without their own hazards such as infection from contact lenses, reduced vision from the ptosis or surgical tarsorrhapy, particularly in only seeing eyes.
Corneal ulcers are usually managed with artificial tears, antibiotic ointment, bandage contact lenses and steroids.
Autologous serum eye drops have been found in uncontrolled trials to be beneficial in these patients, improving the ocular surface and reducing symptoms (Poon et al., 2001; Fox et al., 1984; Tsubota et all, 1999;). In addition, impression cytology and in vitro toxicity testing demonstrated that serum drops have reduced toxicity compared with unpreserved hydroxypropylmethylcellulose (Noble et al., 2004; Poon et al., 2001)
Obtaining serum requires frequent venesection with significant amount of blood taken. It is also expensive. The serum is aliquoted into hundreds of bottles with the additional risk of bacterial contamination. It also requires a fridge and storage facilities for these aliquoted bottles at the patient's home. Because of these requirements some patients are excluded, for example patients with anaemia because they are unable to give blood. In addition, often there is a delay in starting the treatment for organizational and / or funding reasons that can be detrimental to the course of the disease, causing unnecessary surgery and corneal melt resulting in perforation with potential loss of the eye. The FAB method could be used immediately for patients who are awaiting conventional treatment for autologous blood. Furthermore it also appears that 100% autologous serum is more beneficial than 50% serum (Poon et al), thereby larger volumes of blood and/or more frequent venesection is required.
Autologous fresh blood is already used subconjunctivally to help heal leaking trabeculectomy blebs (Dinah et al.2010; Biswas et al. 2009; Burnstein et al. 2001; Haynes et al., 1999). Autologous blood is also used to help attach limbal autografts in cases of pterygium (de Wit et al. 2010) and in vitreoretinal macular hole surgery (Lai et al. 2009; Chuang et al. 2010; McCannel et al. 2008; Lai et al.,2005). No adverse effects have been reported in these studies. The object of this study is to investigate if serum via a drop of fresh blood is an effective treatment for dry eye and corneal ulcers which currently require venesected autologous blood and would be particularly useful in the current group of patients in whom venesection is contraindicated.
If shown to be effective this may replace current autologous serum practice and its ease of use and reduced cost may mean that it could be extended to other ocular surface diseases or moderate dry eyes and used earlier in corneal epithelial defects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fingerprick of autologous blood (FAB) | Experimental | Other: Your own ( autologous) finger prick of blood produced with a diabetic lancetFingerprick of autologous blood (FAB) four times a day for 2 months |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- For Dry Eyes
- Patients with symptoms of dry eyes on at least QDS lubricants and who in addition:
- Break up time (BUT) <5 seconds and Schirmer's test without anaesthesia <5 mm at 5 minutes OR presence of rose bengal /lissamine green or fluorescein staining of the ocular surface OR more than 80% score on OCI due to dry eyes (total score greater than or equal to 29/36)
- For Corneal Ulceration
- Patients with epithelial defects of at least 2 weeks duration where conventional therapy failed. (Conventional therapy includes [if indicated] lubricants, antibiotic ointment, steroids and therapeutic contact lens wear)
Key exclusion criteria (8 listed)
- Fear of needles and unwillingness to carry out repeat finger pricks
- Infected finger or systemic infection or on systemic antibiotics for infection.
- Bleeding disorders and on warfarin anticoagulant therapy
- Epithelial defect was classified as a progressive corneal melt caused by an immunological process such as rheumatoid melt or Mooren's ulceration.
- 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 |
|---|---|---|
| Your own ( autologous) finger prick of blood produced with a diabetic lancet | Other | Fingerprick of autologous blood (FAB) |
Primary outcome
Corneal ulcers / epithelial defects: Ulcers to heal within 4 weeks. Dry eyes: To improve signs (corneal and conjunctival staining, Schirmer's test, tear break up time ) or symptoms ( ocular comfort index questionnaire)
Time frame: One month for corneal ulcers. Dry eyes 2 months.
Follow ups are 3 days, 2 weeks , 4 weeks and 2 months after commencing treatment. Then again 1 month after stopping treatment. Criteria to stop treatment based on patient safety such as finger infection in protocol.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
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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.
Anant Sharma, FRCOphth study chair
Moorfields Eye Hospital NHS Trust and Bedford Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Your own ( autologous) finger prick of blood produced with a diabetic lancet in people with Dry Eyes and Sjogren's Disease With Dry Eyes, run by Bedford Hospital NHS Trust at 1 site in United Kingdom.
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 8 inclusion and 8 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 13 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal ulcers / epithelial defects: Ulcers to heal within 4 weeks. Dry eyes: To improve signs (corneal and conjunctival staining, Schirmer's test, tear break up time ) or symptoms ( ocular comfort index questionnaire) (time frame: One month for corneal ulcers. Dry eyes 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 13 Oct 2016.