Ocular Surface DiseaseNCT03659955
Autologous Blood Treatment for Ocular Surface Disease
A study testing Autologous blood applied to dry eye in people with Ocular Surface Disease, run by NHS Lanarkshire at 1 site in United Kingdom.
Trial summary
In this study, we aim to determine the efficacy of autologous blood as an alternative to autologous serum eye drops (ASE) in people with severe dry eyes and ocular surface inflammation. ASE are drops manufactured from the patient's own blood. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Ocular Surface Disease
- What is being tested?
- Autologous blood applied to dry eye
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Nov 2017to 14 Mar 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Known dry eye and ocular surface disease with or without persistent epithelial defect.
- No improvement in clinical condition after minimum of six months treatment with conventional ocular lubricants.
- No improvement in clinical condition after treatment of all other potential sources of ocular surface disease, including localised and systemic inflammatory disease.
- All topical treatments for dry eye and any other pre-existing ocular conditions are preservative free.
- Patient has capacity to consent to participate in study and to be taught how to administer blood sample.
- Patients aged between 18-100 years.
Who cannot join
- Physical disability preventing patient performing needlestick blood sampling.
- Concurrent ocular infection.
- Globe perforation.
- Patients with known blood borne infections.
- Patients without capacity to consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hairmyres Hospital
East Kilbride, Lanarkshire, G75 8RG
About this study
Official title: Autologous Blood in the Treatment of Severe Dry Eyes and Ocular Surface Disease
In this study, we aim to determine the efficacy of autologous blood as an alternative to autologous serum eye drops (ASE) in people with severe dry eyes and ocular surface inflammation. ASE are drops manufactured from the patient's own blood. Perceived benefits are that human blood contains multiple components that are beneficial to healing and maintaining a healthy ocular surface, including epidermal growth factor, and transforming growth factor β, in addition to fibronectin, vitamin A, and various growth factors. We wish to assess whether administering autologous blood directly to their eye would also be an effective treatment in the management of severe dry eye. It will be the first study analysing the potential benefits of this relatively novel treatment in Scotland and will consider its role in treating an important debilitating condition.
Read the detailed description
The surface of the eye, including the cornea, is dependent on the tear film to protect it. An adequate tear film prevents epithelial breakdown, ulceration and secondary infection. The continual regeneration of the corneal epithelium is supported by various components that reside in human tears, such as growth factors, vitamins, electrolytes and neuropeptides. There are various ocular conditions that can lead to a deficiency in any of these tear constituents and can result in excessive surface dryness. This can lead to corneal surface breakdown, non-healing ulceration, secondary infection, globe perforation and sight loss, in addition to severe pain for patients, all of which can have a significant negative impact on a patient's quality of life. First line therapy in the treatment of tear deficiency is in the form of ocular lubricants. Multiple formulations are available in drop, gel and ointment form. Lubricants act as barriers in one form or another to protect the epithelial surface from mechanical trauma. However, in the presence of an unhealthy tear film or corneal epithelial surface, barrier protection alone is inadequate to promote surface regeneration and wound healing. Therefore, even the use of frequent and continual ocular lubricants may be of no benefit to patients with severe ocular surface disease (OSD).
In this study, we aim to determine the efficacy of autologous blood as an alternative to autologous serum eye drops (ASE) in people with severe dry eyes and ocular surface inflammation. ASE are drops manufactured from the patient's own blood. Perceived benefits are that human blood contains multiple components that are beneficial to healing and maintaining a healthy ocular surface, including epidermal growth factor, and transforming growth factor β, in addition to fibronectin, vitamin A, and various growth factors. We wish to assess whether administering autologous blood directly to their eye would also be an effective treatment in the management of severe dry eye. It will be the first study analysing the potential benefits of this relatively novel treatment in Scotland and will consider its role in treating an important debilitating condition.
- Conditions
- Ocular Surface Disease
- Being tested
- Autologous blood applied to dry eye
- Keywords
- Dry eye, Ocular surface, Autologous 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.
Autologous blood applied to dry eyeOther
See previous description for the study arm.
| Study group | Role | What they receive |
|---|---|---|
| Autologous blood | Experimental | Patients with severe dry eye and ocular surface disease who attend the corneal service within NHS Lanarkshire and who are unresponsive to conservative treatment measures will be considered for treatment of their condition with autologous blood.
Intervention is application of autologous blood. Receives: Other: Autologous blood applied to dry eye |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular surface staining score
To evaluate if the use of autologous blood as described in this study will improve the health of the ocular surface as measured by the ocular surface staining score using the Oxford Grading Scheme.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start7 Nov 2017
- Primary completion3 Oct 2018
- Study completion14 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular Surface DiseaseStudies 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
- Model description
- Cross sectional study
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Lanarkshire
- Sponsor type
- Other government
- Collaborators
- Chief Scientist Office of the Scottish Government, NHS Research Scotland
- Responsible party
- Sponsor
- Investigators
- Douglas Lyall, FRCOphth, Principal investigator, NHS Lanarkshire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659955
- Sponsor's protocol ID
- L17047
- Status last verified
- Apr 2022
- First submitted
- 4 Sep 2018
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Blood in the Treatment of Severe Dry Eyes and Ocular Surface Disease
- ClinicalTrials.gov ID
- NCT03659955
- Acronym / sponsor ID
- L17047
- Conditions
- Ocular Surface Disease
- Keywords
- Dry eye, Ocular surface, Autologous blood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- NHS LanarkshireOther government
- Collaborators
- Chief Scientist Office of the Scottish Government, NHS Research Scotland
- Study start
- 7 Nov 2017 (actual)
- Primary completion
- 3 Oct 2018 (actual)
- Study completion
- 14 Mar 2019 (actual)
- First posted
- 6 Sep 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.
In this study, we aim to determine the efficacy of autologous blood as an alternative to autologous serum eye drops (ASE) in people with severe dry eyes and ocular surface inflammation. ASE are drops manufactured from the patient's own blood. Perceived benefits are that human blood contains multiple components that are beneficial to healing and maintaining a healthy ocular surface, including epidermal growth factor, and transforming growth factor β, in addition to fibronectin, vitamin A, and various growth factors. We wish to assess whether administering autologous blood directly to their eye would also be an effective treatment in the management of severe dry eye. It will be the first study analysing the potential benefits of this relatively novel treatment in Scotland and will consider its role in treating an important debilitating condition.
Detailed description
The surface of the eye, including the cornea, is dependent on the tear film to protect it. An adequate tear film prevents epithelial breakdown, ulceration and secondary infection. The continual regeneration of the corneal epithelium is supported by various components that reside in human tears, such as growth factors, vitamins, electrolytes and neuropeptides. There are various ocular conditions that can lead to a deficiency in any of these tear constituents and can result in excessive surface dryness. This can lead to corneal surface breakdown, non-healing ulceration, secondary infection, globe perforation and sight loss, in addition to severe pain for patients, all of which can have a significant negative impact on a patient's quality of life. First line therapy in the treatment of tear deficiency is in the form of ocular lubricants. Multiple formulations are available in drop, gel and ointment form. Lubricants act as barriers in one form or another to protect the epithelial surface from mechanical trauma. However, in the presence of an unhealthy tear film or corneal epithelial surface, barrier protection alone is inadequate to promote surface regeneration and wound healing. Therefore, even the use of frequent and continual ocular lubricants may be of no benefit to patients with severe ocular surface disease (OSD).
In this study, we aim to determine the efficacy of autologous blood as an alternative to autologous serum eye drops (ASE) in people with severe dry eyes and ocular surface inflammation. ASE are drops manufactured from the patient's own blood. Perceived benefits are that human blood contains multiple components that are beneficial to healing and maintaining a healthy ocular surface, including epidermal growth factor, and transforming growth factor β, in addition to fibronectin, vitamin A, and various growth factors. We wish to assess whether administering autologous blood directly to their eye would also be an effective treatment in the management of severe dry eye. It will be the first study analysing the potential benefits of this relatively novel treatment in Scotland and will consider its role in treating an important debilitating condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cross sectional study
| Arm | Type | Receives |
|---|---|---|
| Autologous blood | Experimental | Other: Autologous blood applied to dry eyePatients with severe dry eye and ocular surface disease who attend the corneal service within NHS Lanarkshire and who are unresponsive to conservative treatment measures will be considered for treatment of their condition with autologous blood. Intervention is application of autologous blood. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Known dry eye and ocular surface disease with or without persistent epithelial defect.
- No improvement in clinical condition after minimum of six months treatment with conventional ocular lubricants.
- No improvement in clinical condition after treatment of all other potential sources of ocular surface disease, including localised and systemic inflammatory disease.
- All topical treatments for dry eye and any other pre-existing ocular conditions are preservative free.
- Patient has capacity to consent to participate in study and to be taught how to administer blood sample.
Key exclusion criteria (5 listed)
- Physical disability preventing patient performing needlestick blood sampling.
- Concurrent ocular infection.
- Globe perforation.
- Patients with known blood borne infections.
- Patients without capacity to consent to participate in the study.
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 |
|---|---|---|
| Autologous blood applied to dry eyeSee previous description for the study arm. | Other | Autologous blood |
Primary outcome
Ocular surface staining score
Time frame: 12 months
To evaluate if the use of autologous blood as described in this study will improve the health of the ocular surface as measured by the ocular surface staining score using the Oxford Grading Scheme.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Ocular Surface Disease
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A Clinical Study to Evaluate the Safety and Effectiveness of MSCohi-O Lens in the Treatment of Immune-related Ocular Surface Diseases.
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Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
Persistent Corneal Epithelial Defect, Corneal Epithelial Disorders
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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.
Douglas Lyall, FRCOphth principal investigator
NHS Lanarkshire
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous blood applied to dry eye in people with Ocular Surface Disease, run by NHS Lanarkshire 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 15 Apr 2022. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ocular surface staining score (time frame: 12 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 15 Apr 2022.