192371-016 Cyclosporine Ophthalmic Solution in Patients with AKC
Research type
Research Study
Full title
A Multicenter, Randomized, Double-Masked, Parallel-Group Study Evaluating the Efficacy and Safety of Cyclosporine Ophthalmic Solution 0.010% Compared with its Vehicle Administered QID for 3 Months Followed by a 9 Month Open-Label Phase in Patients with Atopic Keratoconjunctivitis
IRAS ID
21012
Sponsor organisation
Allergan Ltd.
Eudract number
2009-012446-23
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
Research summary
Atopic Keratoconjunctivitis (AKC) is an inflammatory external disease of the eye which affects both eyes and is the most severe and chronic form of allergy of the eye surface which is often associated with atopic dermatitis, hay fever and/or asthma. AKC is a serious disease caused by chronic inflammation of the cornea, eye surface and lower eye lids. It is a sight threatening condition that may lead to the development of ocular infections, cataracts, blindness and is associated with a high likelihood of permanent visual loss occurring in 1% of those with atopic dermatitis. Symptoms related to AKC include itching of the eye, tearing, burning sensation, light sensitivity, blurred vision and mucous discharge, which persist year round with occasional worsening in the winter and summer months. There are a number of treatment strategies geared towards relieving these symptoms but no evidence exists that demonstrated these therapies may alter the course of the disease. There is evidence to demonstrate that Cyclosporine A, a formulation developed for the treatment of patients with dry eye symptoms, can alleviate the signs and symptoms of patients with Atopic Keratoconjunctivitis. This study uses a solution of Cyclosporine. The potential benefit of using Cyclosporine Solution is that it has been shown to be well tolerated with fewer side effects and the ability to deliver the drug more efficiently in the eye. The Cyclosporine Solution will come in the form of eye drops which the patient will apply themselves up to 4 times daily. The duration of the study is 12 months. This study is estimated to recruit 124 patients in the United States, Canada, Europe (United Kingdom, France, Italy, Germany, Spain and Czech Republic), Australia and New Zealand.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
09/H0904/47
Date of REC Opinion
30 Oct 2009
REC opinion
Further Information Favourable Opinion