Clinical Trial: Topical Cyclosporine for Vernal Keratoconjunctivitis (VKC) in Rwanda

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Topical Cyclosporine in the Treatment of Vernal Keratoconjunctivitis in a Rwandan Eye Clinic; a Prospective Randomized Double-masked Clinical Trial

Brief 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 w

Detailed Summary:
Sponsor: University Hospital, Ghent

Current Primary Outcome: Difference in score for symptoms and clinical signs between treatment arms [ Time Frame: After 4 weeks at the end of 4 weeks test medication ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Speed of symptom/sign reduction [ Time Frame: At 2 weeks while on test medication and at 8 weeks at the end of a chromoglycate maintenance phase ]
  To document any difference between the 2 treatment groups in speed of symptom/sign reduction during the attack treatment and in rebound phenomenon while on chromoglycate during the maintenance phase
• Safety and tolerance of the test medication [ Time Frame: At 2 weeks while on test medication and at 8 weeks at the end of a chromoglycate maintenance phase ]
  To evaluate safety and tolerance of the test medication.

Original Secondary Outcome: Same as current

Information By: University Hospital, Ghent

Dates:
Date Received: September 28, 2010
Date Started: July 2008
Date Completion:
Last Updated: September 28, 2010
Last Verified: September 2010