A Randomized, Double-Masked, Active-Controlled, Crossover Phase III Equivalence Study of Generic Dorzolamide 2% versus Innovator Trusopt® Eye Drop Solution in Subjects with Open-Angle Glaucoma or Ocular Hypertension
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
