Table 3.
Trial schedule.
| Visit action | Screening | Visit 1 | Visit 2 | Visit 3 | Visit 4 |
|---|---|---|---|---|---|
| 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 |