Mean IVCM total scores (±SD) decreased during the study from 10.6 ± 4.2 at baseline to 6.0 ± 2.1 at day 90 (
P = 0.001) in the vCH 0.55% drops group and from 10.8 ± 3.5 at baseline to 9.8 ± 3.8 in the CH 0.10% group (
Table 2;
Fig. 2A). Compared with IVCM images at day 1 (
Fig. 2B), a decrease of crystals was clearly found in the group of CH 0.55% at 30 (
Fig. 2C) and 90 days (
Fig. 2D). However, compared with day 1 (
Fig. 2E), no obvious difference was found in the group of CH 0.10% at 30 (
Fig. 2F) and 90 days (
Fig. 2G). The day 90 score was significantly lower in the vCH 0.55% drops group than in the CH0.10% group (
P = 0.001). For the primary efficacy end point, the absolute change in IVCM total score at day 90 was −4.6 ± 3.1 (relative change: −40 ± 16%) in the vCH 0.55% drops group, which was significantly greater than the absolute change of −0.46 ± 3.38 (relative change: −0.7 ± 33.0%) in the CH 0.10% group (
P < 0.0001). The difference between the absolute changes was 3.8 (95% CI, 2.1−5.6), indicating that vCH 0.55% drops were superior to CH 0.10%. These results were supported by similar findings in the PPS eye population in which vCH 0.55% drops were also superior to CH 0.10% (data not shown). IVCM scores for individual corneal layers in the vCH 0.55% drops group were markedly lower at day 90 than at baseline and, for most layers, were already lower than baseline by day 30 (
Fig. 3). IVCM scores in the individual corneal layers at both time points also tended to be lower in the vCH 0.55% drops group than in the CH 0.10% group. Clinician-assessed photophobia in the vCH 0.55% drops group decreased during the study, paralleling the decrease in IVCM total score (
Fig. 4). In contrast, the photophobia score did not decrease in the CH 0.10% drops group. At day 90, the mean absolute reduction in the photophobia score was significantly greater in the vCH 0.55% drops group than in the CH 0.10% drops group (
P = 0.0048;
Table 3).These results were supported by similar findings in the PPS eye population, with no decrease in photophobia in the CH 0.10% drops group (data not shown).