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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01714960
First Posted: October 26, 2012
Last Update Posted: January 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH
October 24, 2012
October 26, 2012
January 29, 2014
October 2012
December 2013   (Final data collection date for primary outcome measure)
Incidence of adverse events [ Time Frame: Day 1 up to day 23 ]
Same as current
Complete list of historical versions of study NCT01714960 on ClinicalTrials.gov Archive Site
  • Area under the curve (AUC) [ Time Frame: Day 1 to day 17 ]
  • Maximal plasma concentration (Cmax) [ Time Frame: Day 1 to day 17 ]
Same as current
Not Provided
Not Provided
 
Safety and Tolerability of MRZ-99030 Eye Drops in Healthy Volunteers and Glaucoma Patients
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Healthy Volunteers and Glaucoma Patients
  • Drug: MRZ-99030 eye drops 5mg/mL
  • Drug: MRZ-99030 eye drops 20mg/mL
  • Drug: Placebo to MRZ-99030 eye drops
  • Experimental: Healthy volunteers low dose
    MRZ-99030 eye drops (5mg/mL), 1-3 drops three times per day, duration: 16 days.
    Intervention: Drug: MRZ-99030 eye drops 5mg/mL
  • Experimental: Healthy volunteers high dose
    MRZ-99030 eye drops (20mg/mL), 1-3 drops three times per day, duration: 16 days.
    Intervention: Drug: MRZ-99030 eye drops 20mg/mL
  • Experimental: Glaucoma patients
    MRZ-99030 eye drops (20mg/mL), 1-3 drops three times per day, duration: 16 days.
    Intervention: Drug: MRZ-99030 eye drops 20mg/mL
  • Placebo Comparator: Placebo
    Placebo eye drops, 1-3 drops three times per day, duration: 16 days.
    Intervention: Drug: Placebo to MRZ-99030 eye drops
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
December 2013
December 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

For stage 1:

- Healthy volunteers

For stage 2:

- Glaucoma patients

Exclusion Criteria:

For stage 2:

- Any relevant eye disease other than glaucoma

Sexes Eligible for Study: All
35 Years to 80 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01714960
MRZ99030_1001_1
2012-002664-26 ( EudraCT Number )
No
Not Provided
Not Provided
Merz Pharmaceuticals GmbH
Merz Pharmaceuticals GmbH
Not Provided
Study Director: Medical Expert Merz Pharmaceuticals GmbH
Merz Pharmaceuticals GmbH
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP