Healthy Volunteers and Glaucoma PatientsPhase 1NCT01714960
Safety and Tolerability of MRZ-99030 Eye Drops in Healthy Volunteers and Glaucoma Patients
A Phase 1 study testing MRZ-99030 eye drops 5mg/mL and MRZ-99030 eye drops 20mg/mL in people with Healthy Volunteers and Glaucoma Patients, run by Merz Pharmaceuticals GmbH at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 35 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers and Glaucoma Patients
- What is being tested?
- MRZ-99030 eye drops 5mg/mL and MRZ-99030 eye drops 20mg/mL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2012to Dec 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For stage 1:
- Healthy volunteers
- For stage 2:
- Glaucoma patients
Who cannot join
- For stage 2:
- Any relevant eye disease other than glaucoma
Trial locations and contacts
1 site in 1 country.
Germany1 site
Parexel International GmbH, Early Phase Clinical Unit
Berlin, 14050
About this study
- 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.
- Conditions
- Healthy Volunteers and Glaucoma Patients
- Being tested
- MRZ-99030 eye drops 5mg/mL, MRZ-99030 eye drops 20mg/mL, Placebo to MRZ-99030 eye drops
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRZ-99030 eye drops 5mg/mLDrug
MRZ-99030 eye drops 20mg/mLDrug
Placebo to MRZ-99030 eye dropsDrug
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers low dose | Experimental | MRZ-99030 eye drops (5mg/mL), 1-3 drops three times per day, duration: 16 days. Receives: Drug: MRZ-99030 eye drops 5mg/mL |
| Healthy volunteers high dose | Experimental | MRZ-99030 eye drops (20mg/mL), 1-3 drops three times per day, duration: 16 days. Receives: Drug: MRZ-99030 eye drops 20mg/mL |
| Glaucoma patients | Experimental | MRZ-99030 eye drops (20mg/mL), 1-3 drops three times per day, duration: 16 days. Receives: Drug: MRZ-99030 eye drops 20mg/mL |
| Placebo | Placebo comparator | Placebo eye drops, 1-3 drops three times per day, duration: 16 days. Receives: Drug: Placebo to MRZ-99030 eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Measured: Day 1 up to day 23
Secondary outcomes (2)
Area under the curve (AUC)
Measured: Day 1 to day 17
Maximal plasma concentration (Cmax)
Measured: Day 1 to day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers and Glaucoma PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Expert, Study director, Merz Pharmaceuticals GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714960
- Sponsor's protocol ID
- MRZ99030_1001_1
- Other IDs
- 2012-002664-26
- Status last verified
- Jan 2014
- First submitted
- 24 Oct 2012
- Last updated
- 29 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of MRZ-99030 Eye Drops in Healthy Volunteers and Glaucoma Patients
- ClinicalTrials.gov ID
- NCT01714960
- Acronym / sponsor ID
- MRZ99030_1001_1
- Conditions
- Healthy Volunteers and Glaucoma Patients
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Merz Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 26 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers low dose | Experimental | Drug: MRZ-99030 eye drops 5mg/mLMRZ-99030 eye drops (5mg/mL), 1-3 drops three times per day, duration: 16 days. |
| Healthy volunteers high dose | Experimental | Drug: MRZ-99030 eye drops 20mg/mLMRZ-99030 eye drops (20mg/mL), 1-3 drops three times per day, duration: 16 days. |
| Glaucoma patients | Experimental | Drug: MRZ-99030 eye drops 20mg/mLMRZ-99030 eye drops (20mg/mL), 1-3 drops three times per day, duration: 16 days. |
| Placebo | Placebo comparator | Drug: Placebo to MRZ-99030 eye dropsPlacebo eye drops, 1-3 drops three times per day, duration: 16 days. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy volunteers
- Glaucoma patients
Key exclusion criteria (2 listed)
- Any relevant eye disease other than glaucoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRZ-99030 eye drops 5mg/mL | Drug | Healthy volunteers low dose |
| MRZ-99030 eye drops 20mg/mL | Drug | Glaucoma patients, Healthy volunteers high dose |
| Placebo to MRZ-99030 eye drops | Drug | Placebo |
Primary outcome
Incidence of adverse events
Time frame: Day 1 up to day 23
2 secondary outcomes
Area under the curve (AUC)
Time frame: Day 1 to day 17
Maximal plasma concentration (Cmax)
Time frame: Day 1 to day 17
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2014.
Related trials for Healthy Volunteers and Glaucoma Patients
Recruiting
Investigation of Neurovascular Coupling in Glaucoma Patients and Healthy Subjects
Glaucoma, Open-Angle, Normal Tension Glaucoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Expert study director
Merz Pharmaceuticals GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MRZ-99030 eye drops 5mg/mL and MRZ-99030 eye drops 20mg/mL in people with Healthy Volunteers and Glaucoma Patients, run by Merz Pharmaceuticals GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Day 1 up to day 23). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2014.