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

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ClinicalTrials.gov Identifier: NCT01714960
Recruitment Status : Completed
First Posted : October 26, 2012
Last Update Posted : January 29, 2014
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH

Brief 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.

Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Tolerability of MRZ-99030 Eye Drops in Healthy Volunteers and Glaucoma Patients
Study Start Date : October 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Day 1 up to day 23 ]

Secondary Outcome Measures :
  1. Area under the curve (AUC) [ Time Frame: Day 1 to day 17 ]
  2. Maximal plasma concentration (Cmax) [ Time Frame: Day 1 to day 17 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT01714960     History of Changes
Other Study ID Numbers: MRZ99030_1001_1
2012-002664-26 ( EudraCT Number )
First Posted: October 26, 2012    Key Record Dates
Last Update Posted: January 29, 2014
Last Verified: January 2014

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