Topical ciclosporin in the treatment of vernal keratoconjunctivitis in Rwanda, Central Africa: a prospective, randomised, double-masked, controlled clinical trial
- Stefan De Smedt1,
- John Nkurikiye2,
- Yannick Fonteyne1,
- Stephen Tuft3,
- Dirk De Bacquer4,
- Clare Gilbert5,
- Philippe Kestelyn6
- 1Department of Ophthalmology, Kabgayi Hospital, Muhanga, Rwanda
- 2Department of Ophthalmology, King Faisal Hospital, Kigali, Rwanda
- 3Corneal & External Disease Service, Moorfields Eye Hospital NHS Foundation Trust, London, UK
- 4Department of Public Health, Ghent University, Ghent, Belgium
- 5International Centre for Eye Health, London School of Hygiene and Tropical Medicine, London, UK
- 6Department of Ophthalmology, Ghent University Hospital, Ghent, Belgium
- Correspondence to Dr Stefan De Smedt, Leopoldstraat 34, 2800 Mechelen, Belgium;
- Accepted 12 September 2011
- Published Online First 14 October 2011
Aim To compare the short-term efficiency and safety of topical ciclosporin A (CsA) 2% with dexamethasone 0.1% in the treatment of predominantly limbal vernal keratoconjunctivitis (VKC) in Rwanda, Central Africa.
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, best-corrected visual acuity, 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 decreased significantly (p<0.001) from baseline without any 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). In both treatment groups, the visual acuity had improved at 4 weeks compared with baseline (p<0.001) with no significant difference between the treatment arms. 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 efficiency of topical CsA 2% and dexamethasone 0.1% for the management of acute VKC in Central Africa, but tolerance needs to be improved.
- ocular surface
- treatment medical
- treatment medical
- clinical trial
- eye (tissue) banking
- child health (paediatrics)
- public health
- treatment surgery
Funding Belgian Funds for Research in Ophthalmology. NV Novartis Pharma SA (Belgium).
Competing interests None.
Patient consent Obtained.
Ethics approval This study was approved by Rwandan National Ethics Committee.
Provenance and peer review Not commissioned; externally peer reviewed.