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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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

Other trials in United Kingdom

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.

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 groups in NCT02153515
Study groupRoleWhat they receive
Fingerprick of autologous blood (FAB)ExperimentalFingerprick 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.

  1. 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.

  1. First posted3 Jun 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionAug 2017 (estimated)
  4. Study completionNov 2017 (estimated)

Resources

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)
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

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.

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