The main outcome measures were the endothelial cell density (ECD), coefficient of variation (CV), percentages of hexagonal cells (%HEX), and central corneal thickness (CCT). The outcomes were the changes in those parameters from baseline to three months.
A total of 415 patients were included in the study and randomly assigned as follows: 126 patients were treated with latanoprost, 143 with netarsudil, and 126 with the fixed combination. Dr. Wisely reported that there were no statistically significant differences in the changes observed from baseline to month three in the ECD, CV, and %HEX between the fixed-combination group and either component group. Small changes were seen in the CCT ranging from 0.6% to 1.2% in all three groups.
“Mean CCT decreased more in the fixed combination group (-6.4 µm, p<0.0001) than in either the netarsudil group (-3.3 µm, p = 0.0248) or the latanoprost group (-1.2 µm, p<0.0001).” Dr. Wisely reported.
The investigators pointed out some temporary and minor adverse events associated with the drugs. In 18 eyes of nine patients, i.e. four treated with the fixed combination and five treated with netarsudil, transient endothelial cell pleomorphism was seen that resolved by the end of the study without cessation of therapy.
In addition, in 32 eyes of 16 patients, i.e. 10 treated with the fixed combination and six treated with netarsudil, specular microscopy showed distorted endothelial cell morphology that resolved in 15 of the 16 patients by the end of the study.