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

Merz Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers and Glaucoma Patients

Treatments: Drug: MRZ-99030 eye drops 20mg/mL; Drug: MRZ-99030 eye drops 5mg/mL; Drug: Placebo to MRZ-99030 eye drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT01714960

2012-002664-26 (EudraCT Number)

MRZ99030_1001_1

Details and patient eligibility

About

• 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.

Enrollment: 70 patients

Sex: All

Ages: 35 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

For stage 1:

• Healthy volunteers

For stage 2:

• Glaucoma patients

Exclusion criteria

For stage 2:

• Any relevant eye disease other than glaucoma

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 4 patient groups, including a placebo group

Healthy volunteers low dose

Experimental group

Description:

MRZ-99030 eye drops (5mg/mL), 1-3 drops three times per day, duration: 16 days.

Treatment:

Drug: MRZ-99030 eye drops 5mg/mL

Healthy volunteers high dose

Experimental group

Description:

MRZ-99030 eye drops (20mg/mL), 1-3 drops three times per day, duration: 16 days.

Treatment:

Drug: MRZ-99030 eye drops 20mg/mL

Glaucoma patients

Experimental group

Description:

MRZ-99030 eye drops (20mg/mL), 1-3 drops three times per day, duration: 16 days.

Treatment:

Drug: MRZ-99030 eye drops 20mg/mL

Placebo

Placebo Comparator group

Description:

Placebo eye drops, 1-3 drops three times per day, duration: 16 days.

Treatment:

Drug: Placebo to MRZ-99030 eye drops