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Title

Topical ciclosporin in the treatment of vernal keratoconjunctivitis in Rwanda, Central Africa: a randomised, double-masked, controlled clinical trial

Purpose	To compare the short-term efficacy and safety of topical ciclosporin A (CsA) 2% with dexamethasone 0.1% in the treatment of predominantly limbal VKC in Rwanda.
Methods	Consecutive patients with VKC were randomised in a prospective, double-masked, clinical trial to receive either topical CsA 2% dissolved in olive oil vehicle or dexamethasone 0.1% drops for 4 weeks. Both groups then received sodium chromoglycate 2% drops for maintenance therapy for a further 4 weeks. The primary outcome was the reduction in composite score for VKC-related symptoms and signs at 4 weeks. Secondary outcomes included side effects, comfort rating of the trial drops during 4 weeks test medication, and relapse rate thereafter.
Results	The 366 participants recruited had the limbal (91.5%) or mixed form of VKC. At the end of the 4 week treatment period the composite score had significantly (p<0.001) reduced from baseline without a significant difference between CsA and dexamethasone (p= 0.20).There were no severe adverse reactions but CsA drops caused more stinging than the oil placebo and dexamethasone (p<0.001). The relapse rate following cessation of the trial treatments was similar (p= 0.84) in both groups.
Conclusion	There is no significant difference between the efficacy of topical CsA 2% and dexamethasone 0.1% for the management of acute VKC in Central Africa, but tolerance needs to be improved.

Authors 1

Last name	DE SMEDT
Initials	SK
Department	Ophthalmology Department, Ghent University Hospital
City	Gent

Authors 2

Last name	NKURIKIYE
Initials	J
Department	Ophthalmology Department, King Faisal Hospital
City	Kigali, Rwanda

Authors 3

Authors 4

Last name	TUFT
Initials	S
Department	Moorfields Eye Hospital NHS Foundation Trust
City	London, UK

Authors 5

Last name	DE BACQUER
Initials	D
Department	Public Health Department, Ghent University Hospital
City	Gent

Authors 6

Last name	GILBERT
Initials	C
Department	International Centre for Eye Health
City	London, UK

Authors 7

Last name	KESTELYN
Initials	P
Department	Ophthalmology Department, Ghent University Hospital
City	Gent