0.01% RO7058584
DrugOnce daily morning administration for 7 days
NCT Number: NCT03293992
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).
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Notify Me18 year–90 year
All sexes
Interventional
Phase 1
Arizona Eye Center, Chandler, Arizona, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Once daily morning administration for 7 days
Once daily morning administration for 7 days
Once daily morning administration for 7 days
Once daily morning administration for 7 days
Once daily morning or evening dosing
Time frame: Up to 12 weeks
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
Time frame: Up to 12 weeks
Time frame: Up to 12 weeks
Time frame: Up to 12 weeks
Time frame: 7 days
IOP will be assessed by Goldman Applanation tonometry.
Time frame: 7 days
IOP will be assessed by Goldmann Applanation tonometry
Time frame: Up to Day 8
Cmax is the maximum observed plasma concentration.
Time frame: Up to Day 8
Tmax is the time to maximum observed plasma concentration.
Time frame: Up to Day 8
Ctrough is the concentration at the end of a dosing interval before the next dose administration.
Time frame: Up to Day 8
AUC0-24h is the area under the plasma concentration versus time curve (AUC) from Time 0 to 24 h post-dose.
Hoffmann-La Roche
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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