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

Healthy Volunteers and Glaucoma Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01714960
• Other study ID #: MRZ99030_1001_1
• Secondary ID: 2012-002664-26
• Status: Completed
• Phase: Phase 1
• First received: October 24, 2012
• Last updated: January 28, 2014
• Start date: October 2012
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Merz Pharmaceuticals GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 80 Years

Eligibility

Inclusion Criteria:

For stage 1:

• Healthy volunteers

For stage 2:

• Glaucoma patients

Exclusion Criteria:

For stage 2:

• Any relevant eye disease other than glaucoma

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Healthy Volunteers and Glaucoma Patients

Intervention

Drug:
• MRZ-99030 eye drops 5mg/mL

• MRZ-99030 eye drops 20mg/mL

• Placebo to MRZ-99030 eye drops

Locations

Country	Name	City	State
Germany	Parexel International GmbH, Early Phase Clinical Unit	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Merz Pharmaceuticals GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		Day 1 up to day 23	Yes
Secondary	Area under the curve (AUC)		Day 1 to day 17	No
Secondary	Maximal plasma concentration (Cmax)		Day 1 to day 17	No