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Topical Cyclosporine for Vernal Keratoconjunctivitis (VKC) in Rwanda

NCT ID: NCT01211327

Last Updated: 2010-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

366 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2008-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Vernal Keratoconjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cyclosporine A

Cyclosporine A (CsA) 2% eye drops

Group Type EXPERIMENTAL

Cyclosporine A

Intervention Type DRUG

Cyclosporine 2% eye drops

Dexamethasone

Dexamethasone 0,1% eye drops

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

Dexamethasone 0,1% eye drops

Interventions

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Cyclosporine A

Cyclosporine 2% eye drops

Intervention Type DRUG

Dexamethasone

Dexamethasone 0,1% eye drops

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- at least 5 years of age

Exclusion Criteria

* being pregnant
* suffering from any other infectious or inflammatory ocular pathology
* using topical/ systemic corticosteroids, antihistamines, non-steroidal anti-inflammatory drugs or immunosuppressives 2 weeks prior to the trial
* been treated with steroid injection 6 months prior to the study
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Funds for Research in Ophthalmology (FRO) of Belgium

UNKNOWN

Sponsor Role collaborator

Novartis

INDUSTRY

Sponsor Role collaborator

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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University Hospital Ghent

Principal Investigators

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Philippe Kesteleyn, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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Kabgayi Hospital

Gitarama/Muhanga, , Rwanda

Site Status

Countries

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Rwanda

Related Links

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http://www.uzgent.be

Website University Hospital Ghent

Other Identifiers

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UZ Ghent 003

Identifier Type: -

Identifier Source: org_study_id