Topical Cyclosporine for Vernal Keratoconjunctivitis (VKC) in Rwanda
Status:
Completed
Trial end date:
2008-11-01
Target enrollment:
Participant gender:
Summary
Vernal keratoconjunctivitis (VKC) is a bilateral, chronic, external ocular inflammatory
disease of unknown cause. It is a fairly common disease in hot, dry environments,
representing as much as 3% of severe ophthalmic diseases and up to 33% of all eye pathology
seen among young patients in eye clinics in Central Africa. Symptoms and signs can persist
for years with an important visual morbidity and social impact. Corneal changes (e.g. corneal
ulcers) can be sight threatening, occurring in up to 10% of VKC children. Topical steroid
therapy remains the current standard treatment, but in developing countries its use often is
chronic and not medically supervised, potentially leading to bacterial infections,
steroid-induced glaucoma and cataract. Chromoglycate drops have less side effects but lack
the power to control a flare-up. Topical cyclosporine has the potential to offer an efficient
but safer alternative to steroid drops in the management of VKC in an African setting. Its
safety and efficiency in the management of vernal keratoconjunctivitis have been described in
several uncontrolled studies and double-blind, placebo-controlled trials, but those studies
were relatively small and involved populations outside Africa with predominantly palpebral
and mixed forms of VKC. Controversy still remains on the efficiency of cyclosporine in severe
forms of allergic conjunctivitis like VKC. We therefore undertake a larger prospective
randomized double-masked, standard treatment controlled clinical trial in Central Africa to
compare the short-term efficiency of cyclosporine A (CsA) 2% eye drops, solved in olive oil
vehicle, with that of steroid drops in predominantly limbal forms of VKC. During 4 weeks the
participants will be randomised to either cyclosporine or dexamethasone as attack treatment
for VKC. The 4 weeks thereafter all participants will receive chromoglycate drops as
maintenance treatment. Additional objectives are to document any difference in rebound
phenomenon while on chromoglycate during the maintenance phase between the 2 treatment groups
and to evaluate safety and tolerance of the test medication.
Phase:
Phase 4
Details
Lead Sponsor:
University Hospital, Ghent
Collaborators:
Funds for Research in Ophthalmology (FRO) of Belgium Novartis