Skip to main content
OpenTrials
Completed

NCT Number: NCT01714960

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

* 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteers and Glaucoma Patients

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Parexel International GmbH, Early Phase Clinical Unit

Berlin, 14050, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

For stage 1:

  • Healthy volunteers

For stage 2:

  • Glaucoma patients

Exclusion criteria

For stage 2:

  • Any relevant eye disease other than glaucoma

Treatment and study plan

MRZ-99030 eye drops 5mg/mL

Drug

MRZ-99030 eye drops 20mg/mL

Drug

Placebo to MRZ-99030 eye drops

Drug

Primary outcomes

  1. Incidence of adverse events

    Time frame: Day 1 up to day 23

Secondary outcomes

  1. Area under the curve (AUC)

    Time frame: Day 1 to day 17

  2. Maximal plasma concentration (Cmax)

    Time frame: Day 1 to day 17

Sponsors and collaborators

Lead sponsor

Merz Pharmaceuticals GmbH

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 26, 2012
Registry last updated
Jan 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.