Safety and Tolerability of MRZ-99030 Eye Drops in Healthy Volunteers and Glaucoma Patients

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01714960

Enrollment

Registered

2012-10-26

Start date

2012-10-31

Completion date

2013-12-31

Last updated

2014-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers and Glaucoma Patients

Brief summary

* To assess the safety and tolerability of repeat dose topical administration of MRZ-99030 Ophthalmic Solution with ascending doses in healthy subjects (stage 1) and glaucoma subjects (stage 2). * To assess plasma pharmacokinetics and urine concentration of MRZ- 99030 and its metabolite MRZ-9499 after single and repeat dose topical administration of MRZ-99030 Ophthalmic Solution.

Interventions

DRUGMRZ-99030 eye drops 5mg/mL

DRUGMRZ-99030 eye drops 20mg/mL

DRUGPlacebo to MRZ-99030 eye drops

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

35 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

For stage 1: \- Healthy volunteers For stage 2: \- Glaucoma patients

Exclusion criteria

For stage 2: \- Any relevant eye disease other than glaucoma

Design outcomes

Primary

Measure	Time frame
Incidence of adverse events	Day 1 up to day 23

Secondary

Measure	Time frame
Area under the curve (AUC)	Day 1 to day 17
Maximal plasma concentration (Cmax)	Day 1 to day 17

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026