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

This study is currently recruiting participants.
Verified May 2013 by Merz Pharmaceuticals GmbH
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT01714960
First received: October 24, 2012
Last updated: May 22, 2013
Last verified: May 2013
History of Changes
  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:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

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 ]

Estimated Enrollment: 70
Study Start Date: October 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01714960

Contacts
Contact: Manager Public Disclosure clinicaltrials@merz.de

Locations
Germany
Parexel International GmbH, Early Phase Clinical Unit Recruiting
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: May 22, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on May 23, 2013