Topical Cyclosporine for Vernal Keratoconjunctivitis (VKC) in Rwanda

NCT01211327 | Completed Phase 4

• 1 other identifier: UZ Ghent 003
• Study Type: interventional
• Target: 366
• Locations: 1 country
• Sites: 1

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.

Conditions

Vernal Keratoconjunctivitis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Speed of symptom/sign reduction

  At 2 weeks while on test medication and at 8 weeks at the end of a chromoglycate 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

Study Arms (2)

Cyclosporine A

EXPERIMENTAL

Cyclosporine A (CsA) 2% eye drops

Drug: Cyclosporine A

Dexamethasone

ACTIVE COMPARATOR

Dexamethasone 0,1% eye drops

Drug: Dexamethasone

Interventions

Cyclosporine A DRUG

Cyclosporine 2% eye drops

Cyclosporine A

Dexamethasone DRUG

Dexamethasone 0,1% eye drops

Dexamethasone

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- at least 5 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Funds for Research in Ophthalmology (FRO) of Belgium: collaborator
• Novartis: collaborator

Study Sites (1)

Kabgayi Hospital

Gitarama/Muhanga, Rwanda

Location

Related Links

• Website University Hospital Ghent

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

Cyclosporine; Dexamethasone

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated

Study Officials

• Philippe Kesteleyn, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 28, 2010
• First Posted: September 29, 2010
• Study Start: July 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: September 29, 2010

Record last verified: 2010-09

Locations

RW (1)