Recruiting Research Studies Cornea & External Disease research at Moorfields Moorfields Eye Hospital wants to improve access to clinical research studies for all patients within the NHS and provide the opportunities for patients to participate in research. This is a list of research studies that are currently open and recruiting patients at Moorfields Eye Hospital. This includes information about the study, the lead consultant on the study, and the currently anticipated date that patient recruitment will end. If no end date is stated, then the study has no set end date and will continue to recruit patients for the foreseeable future. If you are interested in any of the listed studies, we advise that you approach your Moorfields consultant for more information. If you are not a Moorfields patient, you will need to be referred to Moorfields Eye Hospital by your NHS GP to be able to participate in any of these studies. For further information, please e-mail res-admin@moorfields.nhs.uk If a member of our staff thinks you might meet the specific criteria for a study, they will discuss it with you in detail. You might be approached during your visit to the hospital, or receive a letter or phone call after your visit. You will be given time to consider whether you would like to take part and what the implications will be for you. All clinical research projects are strictly monitored by our research department and regulated by national bodies. You will need to give explicit written consent if you decide you would like to take part. Version: 1 Page 1 of 5 Status: PUBLISHED Approved: 17 th August 2018 Ratified: 17 th August 2018
AHMS1001 Inflammation in ocular surface disease The aim of the study is to determine if inflammatory molecules, proteins and cells (markers) found in tissues affected in ocular surface inflammatory diseases such as conjunctivitis (inflammation of the conjunctiva: the lining of the back surface of the eyelids and the white of the eye (sclera)) and keratitis (inflammation of the clear window called the cornea) differ. We are particularly interested in diseases that may affect numerous parts of the body as well as the eyes such as Mucous Membrane Pemphigoid (MMP), Stevens - Johnson syndrome/ Toxic Epidermal Necrolysis (SJS-TEN) and Sjögren s syndrome which may cause severe damage to the lining of the mouth or skin as well as potentially blinding inflammation of the surface of the eye. Some of this damage results in scarring (fibrosis) affecting the conjunctiva and eventually the cornea. The aim is to determine if these markers correlate with the severity of disease; whether they differ in tears, the ocular surface, saliva, peripheral blood and urine between different disease types and healthy controls (volunteers, relatives and friends of our patients). Consultant: Mr Sajjad Ahmad Recruitment End Date: 31/12/2021 AHMS1003 The Feasibility of Fingerprick Autologous Blood (FAB) As a Novel Treatment for Severe Dry Eye Disease (DED): A Randomised Controlled Trial (FAB study) This study proposes to test the use of whole, fresh, autologous blood as a treatment for severe dry eye disease This study proposes to test the use of fingerprick autologous blood (FAB) technique in which whole blood is applied to the eye from a cleaned finger. Autologous fresh blood is already used sub-conjunctively to help heal leaking trabeculectomy blebs. It is also used to help attach limbal autografts in cases of pterygium and vitreoretinal macular hole surgery, with no adverse effects reported. The FAB method can be used immediately for patients who are awaiting conventional treatment for autologous blood. The objective of this study is therefore to investigate if serum via a drop of fresh blood is an effective treatment for severe dry eye disease which currently require venesected autologous blood and whether this would be particularly useful in the group of patients in whom venesection is contraindicated or funding is not available. Consultant: Mr Sajjad Ahmad Recruitment End Date: TBC Cornea & External Disease Research at Moorfields Page 2 of 5
CROR1002 Dry eye Outcome and Prescription Study (DROPS) Dry eye disease is a disorder of the surface of the eye and causes light sensitivity, grittiness, pain and blurred vision. These symptoms interfere highly with quality of life. Dry eye affects around 20% of people and is more prevalent in women and older age. In the majority of cases no cure is available and the cornerstone of treatment is symptom control with artificial tears. With this study we want to investigate determinants of the effectiveness of artificial tears in patients with dry eye disease and to investigate underlying factors for consultants' selection of different artificial tears. There are few well designed studies examining the effectiveness of different artificial tears and none have investigated effectiveness in the 'real world', which is surprising given this problem makes up 30% of ophthalmology consultations. Consultant: : Dr Roxanne Crosby-Nwaobi Recruitment End Date: 01/04/2021 DARJ1022 Randomized, Assessor-Masked, Active-Controlled, Phase 3 Study to Evaluate Efficacy, Safety and Tolerability of 0.08% Polyhexamethylene Biguanide (PHMB) Ophthalmic Solution in Comparison with 0.02% PHMB + 0.1% Propamidine Combination Therapy in Subjects Affected by Acanthamoeba keratitis (ODAK) Acanthamoeba keratitis (AK) is an uncommon, severe, corneal infection, first described in 1975. Over 90% of cases are in contact lens users, and result from exposure to contaminated fluids. The international incidence is highest in the UK (50 to 200 new cases per year in England) probably due to contamination of domestic tank-stored water. Acanthamoeba is a single celled organism and difficult to eradicate in the cyst form, in which it survives in the cornea. The infection is persistent, accompanied by debilitating pain and inflammation, with current best treatment curing only 70% of patients in 12 months. In 1992 unlicensed PHMB 0.02% eye drops were introduced, becoming a treatment breakthrough. Before this only 1 of the first 20 patients treated had a good outcome. PHMB 0.02%, to which there is no resistance in laboratory tests, was rapidly introduced world-wide and often combined with propamidine (Brolene), a less effective drug introduced earlier. Although 70% of cases are cured with this combination a major reason for the 30% with a poor outcome is due to poor penetration of the drug. Because the development work, to assess the safety of PHMB as an eye drop had not been done, higher concentrations of PHMB, with better penetration, have not been assessed. The Orphan Drug for AK (ODAK) project was EU funded in 2012 to carry out the studies needed to develop PHMB as a licensed drug for AK. These have resulted in the development of concentrated PHMB 0.08%, which is expected to reduce treatment failures. This proposed randomised controlled trial, comparing PHMB 0.08% to PHMB 0.02% and Brolene, is the last study required by the European Medicines Agency to license PHMB 0.08% as treatment for AK. A successful outcome will be a major step forward for patients, resulting in an effective licensed preparation Consultant: Prof John Dart Recruitment End Date: 31/10/2018 Cornea & External Disease Research at Moorfields Page 3 of 5
LARF1019 KERALINK: Efficacy and safety of cross-linking in children with Keratoconus Keratoconus is a long-term eye disorder characterised by the thinning and bulging of the normally round cornea into a cone-like shape that causes progressive distortion of vision. In advanced cases, corneal replacement by a transplant is needed. Corneal collagen cross-linking (CXL) is a procedure that involves the removal of the surface layer of the cornea (epithelium-off CXL), the administration of riboflavin (vitamin B2) eye drops and exposure of the cornea to UV light. The aim is to study the efficacy and safety of epithelium-off CXL in children (10-16 years) with keratoconus, and to compare it to standard care with provision of glasses and/or contact lenses as required for best vision. Sixty eligible children aged 10-16 years with mild to moderate keratoconus will be randomised to participate in the study. Participants will be followed up at 3-monthly visits for 18 months, and those with unconfirmed progression at the 18 month visit will have an additional 21 month visit to confirm progression. The primary outcome measures of the study are whether cross-linking is efficacious and safe in patients under 17 years. Consultant: Frank Larkin and Steve Tuft Recruitment End Date: 30/09/2018 LARF1020 Efficacy and safety assessment of T1580 versus vehicle in dry eye disease treatment This phase III study aims at evaluating the efficacy and safety of T1580 administered once daily for 12 months in menopausal women with moderate to severe keratitis caused by DED. The first 6-month period will be double-masked versus vehicle and will be followed by an open-label 6-month period during which all patients will receive T1580. As T1580 is a preservative-free aqueous solution, it is expected to decrease the rate of local side effects observed with current CsA ophthalmic emulsions (IKERVIS and RESTASIS ). This clinical study is expected to demonstrate the superiority of T1580, which was developed as a new preservative-free CsA ophthalmic aqueous solution, versus vehicle in terms of efficacy and to evaluate its ocular tolerability and safety in a well-defined and homogenous population composed of menopausal patients with moderate to severe keratitis caused by DED, which has not improved despite treatment with tear substitutes. Consultant: Mr Frank Larkin Recruitment End Date: 31/12/2018 Cornea & External Disease Research at Moorfields Page 4 of 5
TUFS1019 Phenotype-genotype correlation of Fuchs corneal dystrophy This research aims to find out more about the genetic factors in Fuchs Corneal Dystrophy and to find the genes that affect the risk of developing Fuchs Corneal Dystrophy. Consultant: Mr Steve Tuft Recruitment End Date: TBC Cornea & External Disease Research at Moorfields Page 5 of 5