Trial day |
Day −28 to 1 |
Day 1 |
Day 28 ± 5 |
Day 35−1/+3 |
Day 63 ± 5 |
Demographics (sex, age) |
x |
|
|
|
|
Patient information and informed consent |
X |
|
|
|
|
Previous and concomitant diseases |
X |
|
|
|
|
Previous and concomitant treatments |
X |
|
|
|
|
Inclusion/exclusion criteria |
X |
|
|
|
|
Vital signs (blood pressure, pulse) |
X |
|
X |
|
X |
Best-corrected visual acuity |
X |
X |
X |
X |
X |
Pregnancy test (if woman of childbearing potential) |
X |
|
|
|
|
Laboratory tests |
X |
|
X |
|
X |
IOP (8.00, 12.00, and 16.00 ± 1 h) |
X |
X |
X |
X |
X |
Application of study medication by study personnel (16 : 00 ± 1 h, after IOP measurement) |
|
X |
|
X |
|
Randomization |
|
X |
|
|
|
Slit-lamp examination |
X |
X |
X |
X |
X |
Dilated fundus examination |
X |
|
|
|
X |
Dispensation of study medication |
|
X |
|
X |
|
Symptom survey |
|
|
X |
|
X |
Changes in medical health or concomitant medication |
|
X |
X |
X |
X |
Adverse events |
|
X |
X |
X |
X |
End of trial (final visit) |
|
|
|
|
X |