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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT01714960
First received: October 24, 2012
Last updated: January 28, 2014
Last verified: January 2014

October 24, 2012
January 28, 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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
  • Maximal plasma concentration (Cmax) [ Time Frame: Day 1 to day 17 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Both
35 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01714960
MRZ99030_1001_1, 2012-002664-26
No
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