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

Phase 1

Completed

• Conditions: Healthy Volunteers and Glaucoma Patients
• Interventions: Drug: MRZ-99030 eye drops 5mg/mL; Drug: MRZ-99030 eye drops 20mg/mL; Drug: Placebo to MRZ-99030 eye drops

• Registration Number: NCT01714960
• Lead Sponsor: Merz Pharmaceuticals GmbH

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-24
• Study First Submitted QC: 2012-10-24
• Study First Posted: 2012-10-26
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-28
• Last Update Posted: 2014-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

For stage 1:

• Healthy volunteers

For stage 2:

• Glaucoma patients

Read More

Exclusion Criteria

For stage 2:

• Any relevant eye disease other than glaucoma

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy volunteers low dose	MRZ-99030 eye drops 5mg/mL	MRZ-99030 eye drops (5mg/mL), 1-3 drops three times per day, duration: 16 days.
Healthy volunteers high dose	MRZ-99030 eye drops 20mg/mL	MRZ-99030 eye drops (20mg/mL), 1-3 drops three times per day, duration: 16 days.
Glaucoma patients	MRZ-99030 eye drops 20mg/mL	MRZ-99030 eye drops (20mg/mL), 1-3 drops three times per day, duration: 16 days.
Placebo	Placebo to MRZ-99030 eye drops	Placebo eye drops, 1-3 drops three times per day, duration: 16 days.

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	Day 1 up to day 23

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Parexel International GmbH, Early Phase Clinical Unit; 🇩🇪 Berlin, Germany