Topical Cyclosporine for Vernal Keratoconjunctivitis (VKC) in Rwanda

Sponsor

University Hospital, Ghent (Other)

Overall Status

Completed

CT.gov ID

NCT01211327

Collaborator

Funds for Research in Ophthalmology (FRO) of Belgium (Other), Novartis (Industry)

366

Enrollment

Location

Arms

Duration (Months)

90.6

Patients Per Site Per Month

Study Details

Study Description

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 while on chromoglycate during the maintenance phase between the 2 treatment groups and to evaluate safety and tolerance of the test medication.

Condition or Disease	Intervention/Treatment	Phase
Vernal Keratoconjunctivitis	Drug: Cyclosporine A Drug: Dexamethasone	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

366 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2008

Actual Primary Completion Date :

Nov 1, 2008

Actual Study Completion Date :

Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cyclosporine A Cyclosporine A (CsA) 2% eye drops	Drug: Cyclosporine A Cyclosporine 2% eye drops
Active Comparator: Dexamethasone Dexamethasone 0,1% eye drops	Drug: Dexamethasone Dexamethasone 0,1% eye drops

Arm

Intervention/Treatment

Experimental: Cyclosporine A

Cyclosporine A (CsA) 2% eye drops

Drug: Cyclosporine A

Cyclosporine 2% eye drops

Active Comparator: Dexamethasone

Dexamethasone 0,1% eye drops

Drug: Dexamethasone

Dexamethasone 0,1% eye drops

Outcome Measures

Primary Outcome Measures

Difference in score for symptoms and clinical signs between treatment arms [After 4 weeks at the end of 4 weeks test medication]
Differences in scores for symptoms and clinical signs individually and as a composite score between the treatment arms. Symptoms are itchiness, tearing, stinging, discharge and photophobia. Signs are subtarsal scarring, limbal cysts, pseudogerontoxon, pseudomembrane, corneal plaque, shield-ulcer, bulbar hyperaemia, limbal pigmentation, punctate keratitis, tarsal plate papillae, corneal astigmatism, limbal follicles, conjunctivalisation of the cornea and trantas dots.

Secondary Outcome Measures

Speed of symptom/sign reduction [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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