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
  Purpose
  • 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.

Condition Intervention Phase
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
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Tolerability of MRZ-99030 Eye Drops in Healthy Volunteers and Glaucoma Patients

Resource links provided by NLM:


Further study details as provided by Merz Pharmaceuticals GmbH:

Primary Outcome Measures:
  • Incidence of adverse events [ Time Frame: Day 1 up to day 23 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 70
Study Start Date: October 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Healthy volunteers low dose
MRZ-99030 eye drops (5mg/mL), 1-3 drops three times per day, duration: 16 days.
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.
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.
Drug: MRZ-99030 eye drops 20mg/mL
Placebo Comparator: Placebo
Placebo eye drops, 1-3 drops three times per day, duration: 16 days.
Drug: Placebo to MRZ-99030 eye drops

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

For stage 1:

- Healthy volunteers

For stage 2:

- Glaucoma patients

Exclusion Criteria:

For stage 2:

- Any relevant eye disease other than glaucoma

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01714960

Locations
Germany
Parexel International GmbH, Early Phase Clinical Unit
Berlin, Germany, 14050
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
Investigators
Study Director: Medical Expert Merz Pharmaceuticals GmbH
  More Information

No publications provided

Responsible Party: Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT01714960     History of Changes
Other Study ID Numbers: MRZ99030_1001_1, 2012-002664-26
Study First Received: October 24, 2012
Last Updated: January 28, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Tetrahydrozoline
Ophthalmic Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on October 19, 2014