The present study was performed in adherence to the Declaration of
Helsinki and the Good Clinical Practice (GCP) guidelines of the
European Union. After approval of the study protocol by the Ethics
Committee of the Vienna University School of Medicine and after written
informed consent was obtained, 12 healthy male subjects were studied
(mean ± SD age, 25.6 ± 2.4 years). All subjects passed a
prestudy screening during the 4 weeks before the first study day, which
included medical history and physical examination; 12-lead
electrocardiogram; complete blood count; activated partial
thromboplastin time; thrombin time; clinical chemistry (sodium,
potassium, creatinine, uric acid, glucose, cholesterol, triglycerides,
alanine aminotransferase, aspartate transcarbamylase,γ
-glutamyltransferase, alkaline phosphatase, total bilirubin, and
total protein); hepatitis A, B, C, and HIV serology; urine analysis;
and an ophthalmic examination. Subjects were excluded if any
abnormality was found as part of the pretreatment screening unless the
investigators considered an abnormality to be clinically irrelevant. In
addition, subjects with normal findings from the screening examinations
and with ametropia of less than 3 diopters were included in the trial.
Mean baseline intraocular pressure (IOP) of the subjects was 14.5 ± 2.1 mm Hg. During the last week after completion of the study a
follow-up safety investigation was scheduled. This follow-up
investigation included complete blood count, activated partial
thromboplastin time, thrombin time, clinical chemistry (sodium,
potassium, creatinine, uric acid, glucose, cholesterol, triglycerides,
alanine aminotransferase, aspartate transcarbamylase,γ
-glutamyltransferase, alkaline phosphatase, total bilirubin, and
total protein), and urine analysis.