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Topical Cyclosporine for Vernal Keratoconjunctivitis (VKC) in Rwanda

NCT01211327 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 366

Last updated 2010-09-29

No results posted yet for this study

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.

Conditions

  • Vernal Keratoconjunctivitis

Interventions

DRUG

Cyclosporine A

Cyclosporine 2% eye drops

DRUG

Dexamethasone

Dexamethasone 0,1% eye drops

Sponsors & Collaborators

  • Funds for Research in Ophthalmology (FRO) of Belgium

    collaborator UNKNOWN

  • Novartis

    collaborator INDUSTRY

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Philippe Kesteleyn, MD, PhD · University Hospital, Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • Rwanda

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01211327 on ClinicalTrials.gov