Discussion
VKC [, impaired vision, VKC, corneal ulceration, active VKC, keratitis, rhinorrhoea, headache, CFS
CORNEAL ULCERATION, KERATITIS, SCARRING, COMPLICATIONS
Pooled analysis of data from the NOVATIVE and VEKTIS studies indicate that both regimens were significantly more effective than vehicle in improving keratitis as measured by CFS scores in patients with VKC. Improvements were observed by 28 days after treatment initiation. Although other efficacy endpoints were evaluated in the NOVATIVE and VEKTIS trials, only CFS scores were included in these pooled analyses because the approaches to assessment of corneal staining were comparable in both the trials. The CFS score is particularly important in the assessment of patients with VKC because it directly assesses corneal involvement and the risks for complications such as corneal ulceration and scarring that may result in impaired vision [Pooled analysis of data from the NOVATIVE and VEKTIS studies also demonstrated that high- and low- dose regimens of CsA CE were safe and well tolerated. The most frequently reported AEs were usually non-serious, transitory, and mild or moderate in severity. In addition, only 2 systemic AEs were reported, 1 patient each with headache or rhinorrhoea. The favourable safety profile for CsA CE demonstrated by this pooled analysis of 4-week safety data is supported by longer term follow-up of patients receiving CsA CE for up to 12 months in the VEKTIS trial [No clinically significant changes in visual acuity, IOP, or slit lamp examination findings were reported with long-term use of CsA CE [The pooled safety analysis for CsA CE indicates that the high-dose regimen is as safe and tolerable as the lower dose. This result, coupled with its long-term efficacy, prompted selection of 1 drop of CsA CE 0.1% instilled 4 times per day as the recommended dosing regimen [The limitations of pooled analyses are well documented, particularly when pooling studies with different populations, treatment practices, or designs [Combining results from different treatment regimens might also be expected to increase the heterogeneity of results and to decrease the probability of detecting a significant difference compared with control [The results from these pooled analyses support the conclusion that CsA CE is safe, well tolerated, and significantly improves keratitis in patients with active VKC. Combined with previously published data on the efficacy of CsA CE in paediatric VKC [