NCT03293992

A Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7058584 Following 7 Days of Instillation of Eye Drops in Patients With Primary Open Angle Glaucoma or Ocular Hypertension

A Phase I, Multi-Center, Randomized, Adaptive, Investigator/Patient Masked, Multiple-Ascending Dose, Placebo and Active Comparator-Controlled Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7058584 Following 7 Days of Topical Instillation of Eye Drops in Patients With Primary Open Angle Glaucoma or Ocular Hypertension

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I, multi-center, randomized, adaptive, investigator/patient-masked, placebo-controlled, parallel multiple-ascending dose study (Part A) with an extension including up to two selected doses from Part A and latanoprost 0.005% as active comparator (Part B).

Conditions

• Glaucoma, Open-angle
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	0.01% RO7058584	Once daily morning administration for 7 days
DRUG	0.1% RO7058584	Once daily morning administration for 7 days
DRUG	1% RO7058584	Once daily morning administration for 7 days
DRUG	Matching Placebo	Once daily morning administration for 7 days
DRUG	Latanoprost 0.005%	Once daily morning or evening dosing

Timeline

• Start date: 2017-10-10
• Primary completion: 2017-12-15
• Completion: 2017-12-21
• First posted: 2017-09-26
• Last updated: 2020-03-31

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study