Disposition
DISEASE
In the NOVATIVE trial, 118 patients were enrolled and randomised. The safety and efficacy analysis sets (full analysis set) included all patients who received treatment. At the end of the first period (day 28), 111 patients (94.1%) remained in the trial: 4 patients withdrew from the vehicle group, and 3 from the CsA CE 0.1% group. The most common reasons for discontinuation among patients who withdrew were worsening of disease (42.9%, all in vehicle group) and patient decision/withdrawal of consent (28.6%, all in CsA CE 0.1% group).In the VEKTIS trial, a total of 169 patients were randomised to study treatment. Of these, 143 (84.6%) completed the 4-month treatment period. Of those who did not complete treatment period, 9 were in the vehicle group, 11 were in the CsA CE 0.1% BID group, and 6 were in the QID group. The most frequent reasons for discontinuation among withdrawn patients were lack of efficacy (42.3%) and patient decision unrelated to an AE (26.9%) [