Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002664-26 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy volunteers low dose | Experimental | MRZ-99030 eye drops (5mg/mL), 1-3 drops three times per day, duration: 16 days. |
|
| Healthy volunteers high dose | Experimental | MRZ-99030 eye drops (20mg/mL), 1-3 drops three times per day, duration: 16 days. |
|
| Glaucoma patients | Experimental | MRZ-99030 eye drops (20mg/mL), 1-3 drops three times per day, duration: 16 days. |
|
| Placebo | Placebo Comparator | Placebo eye drops, 1-3 drops three times per day, duration: 16 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRZ-99030 eye drops 5mg/mL | Drug |
| ||
| MRZ-99030 eye drops 20mg/mL |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Day 1 up to day 23 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (AUC) | Day 1 to day 17 | |
| Maximal plasma concentration (Cmax) | Day 1 to day 17 |
Not provided
Inclusion Criteria:
For stage 1:
- Healthy volunteers
For stage 2:
- Glaucoma patients
Exclusion Criteria:
For stage 2:
- Any relevant eye disease other than glaucoma
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Expert | Merz Pharmaceuticals GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel International GmbH, Early Phase Clinical Unit | Berlin | 14050 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| Placebo to MRZ-99030 eye drops | Drug |
|