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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
27
Once daily morning administration for 7 days
Once daily morning administration for 7 days
Once daily morning administration for 7 days
Arizona Eye Center
Chandler, Arizona, United States
Sall Research Medical Center
Artesia, California, United States
United Med Res Inst
Inglewood, California, United States
Eye research foundation
Newport Beach, California, United States
Incidence, Severity, and Causal Relationship of Ocular and Systemic Adverse Events (AEs)
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: Up to 12 weeks
Incidence of Abnormal Laboratory Findings
Time frame: Up to 12 weeks
Incidence of Blood Pressure Abnormalities
Time frame: Up to 12 weeks
Incidence of Pulse Rate Abnormalities
Time frame: Up to 12 weeks
Incidence of Electrocardiogram (ECG) Findings
Time frame: Up to 12 weeks
Change From Baseline in Mean Intraocular pressure (IOP) After 7 Days of Study Drug Administration
IOP will be assessed by Goldman Applanation tonometry.
Time frame: 7 days
Change From Baseline in Mean Intraocular pressure (IOP) at Matched Clock-Times After 7 Days of Study Drug Administration
IOP will be assessed by Goldmann Applanation tonometry
Time frame: 7 days
Cmax of RO7058584
Cmax is the maximum observed plasma concentration.
Time frame: Up to Day 8
Tmax of RO7058584
Tmax is the time to maximum observed plasma concentration.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Once daily morning administration for 7 days
Once daily morning or evening dosing
Rocky Mountain Lions Eye Inst
Aurora, Colorado, United States
Eye Care Centers Management, Inc. (Clayton Eye Center)
Morrow, Georgia, United States
Coastal Research Associates
Roswell, Georgia, United States
Texan Eye/Keystone Research
Austin, Texas, United States
Time frame: Up to Day 8
Ctrough of RO7058584
Ctrough is the concentration at the end of a dosing interval before the next dose administration.
Time frame: Up to Day 8
AUC0-24h of RO7058584
AUC0-24h is the area under the plasma concentration versus time curve (AUC) from Time 0 to 24 h post-dose.
Time frame: Up to Day 8