Dry Eye Syndromes Clinical Trial
— FABOfficial 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.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | July 2019 |
Est. primary completion date | April 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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) - Systemic illness causing immune system deficiency - Graft versus host disease - Previous use of autologous serum within 3 months |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Bedford Hospital NHS Trust | Anglia Ruskin University |
Fox 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. — View Citation
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. — View Citation
Than 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. — View Citation
Tsubota K, Goto E, Fujita H, Ono M, Inoue H, Saito I, Shimmura S. Treatment of dry eye by autologous serum application in Sjögren's syndrome. Br J Ophthalmol. 1999 Apr;83(4):390-5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 12 months | |
Primary | Number of patients who adhere to trial protocol | Measured by self-reported adherence to trial protocol | 12months | |
Secondary | 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 | 3 months | |
Secondary | 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 | 3 months | |
Secondary | Improvement in objective signs of dry eye disease as indicated by visual acuity | This will be assessed using the Snellen chart | 3 months | |
Secondary | Willingness for patients to be randomised and acceptability of the intervention | This will be assessed by structured qualitative interviews | 3 months | |
Secondary | Impact on patients' quality of life | This will be assessed by EQ-5D-5L score with higher scores indicating improvement in quality of life | 3 months | |
Secondary | 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 | 3 months | |
Secondary | Intraocular pressure (IOT) | Intraocular pressure will be measured to assessed safety of the intervention | 3 months |
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