Topical Cyclosporine for Vernal Keratoconjunctivitis (VKC) in Rwanda

Vernal Keratoconjunctivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01211327
• Other study ID #: UZ Ghent 003
• Status: Completed
• Phase: Phase 4
• First received: September 28, 2010
• Last updated: September 28, 2010
• Start date: July 2008
• Est. completion date: November 2008

Study information

• Verified date: September 2010
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Rwanda: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 366
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Conjunctivitis, Allergic
• Keratoconjunctivitis
• Vernal Keratoconjunctivitis

Intervention

Drug:
• Cyclosporine A
Cyclosporine 2% eye drops
• Dexamethasone
Dexamethasone 0,1% eye drops

Locations

Country	Name	City	State
Rwanda	Kabgayi Hospital	Gitarama/Muhanga

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Ghent	Funds for Research in Ophthalmology (FRO) of Belgium, Novartis

Country where clinical trial is conducted

Rwanda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in score for symptoms and clinical signs between treatment arms	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.	After 4 weeks at the end of 4 weeks test medication	No
Secondary	Speed of symptom/sign reduction	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	At 2 weeks while on test medication and at 8 weeks at the end of a chromoglycate maintenance phase	No
Secondary	Safety and tolerance of the test medication	To evaluate 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	Yes

External Links

•   Website University Hospital Ghent