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0.01% RO7058584

Phase 1

Glaucoma, Open-angle | Small molecule | Ophthalmology |Roche Holding AG|Last Updated: Mar 31, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

Clinical trial landscape

0.01% RO7058584 · 1 trial · 2 indications

Phase 1 1
NCT03293992A 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 HypertensionGlaucoma, Open-angle
COMPLETED27 Analytics
PHASE1COMPLETED
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
Glaucoma, Open-angleUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence, Severity, and Causal Relationship of Ocular and Systemic Adverse Events (AEs)
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.

Incidence of Abnormal Laboratory Findings
Up to 12 weeks
Incidence of Blood Pressure Abnormalities
Up to 12 weeks
Incidence of Pulse Rate Abnormalities
Up to 12 weeks
Incidence of Electrocardiogram (ECG) Findings
Up to 12 weeks
Change From Baseline in Mean Intraocular pressure (IOP) After 7 Days of Study Drug Administration
7 days

IOP will be assessed by Goldman Applanation tonometry.

Secondary Endpoints

Change From Baseline in Mean Intraocular pressure (IOP) at Matched Clock-Times After 7 Days of Study Drug Administration
7 days
Cmax of RO7058584
Up to Day 8
Tmax of RO7058584
Up to Day 8
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
0.01% RO7058584 or Matching PlaceboEXPERIMENTAL -
0.1% RO7058584 or Matching PlaceboEXPERIMENTAL -
1% RO7058584 or Matching PlaceboEXPERIMENTAL -
RO7058584 and Latanoprost 0.005%EXPERIMENTAL -

Interventions

NameTypeDescription
0.01% RO7058584DRUGOnce daily morning administration for 7 days
0.1% RO7058584DRUGOnce daily morning administration for 7 days
1% RO7058584DRUGOnce daily morning administration for 7 days
Matching PlaceboDRUGOnce daily morning administration for 7 days
Latanoprost 0.005%DRUGOnce daily morning or evening dosing
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Eligibility Criteria

Age Range18 Years to 90 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * 18 to 90 years of age inclusive, at the time of signing the informed consent form * Confirmed diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG) in both eyes as determined by the investigator at screening * Treatment-naïve participants or participants...

Countries:United States
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Frequently asked questions about 0.01% RO7058584

What is 0.01% RO7058584 used for?

0.01% RO7058584 is an investigational small molecule being developed by Roche for the treatment of glaucoma and open-angle glaucoma. It is administered as an eye drop and is currently in Phase 1 clinical development for these ophthalmic conditions.

Who makes 0.01% RO7058584?

0.01% RO7058584 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The drug is an investigational small molecule in Phase 1 clinical development for the treatment of glaucoma and open-angle glaucoma.

What phase is 0.01% RO7058584 in?

0.01% RO7058584 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study of the drug has been completed in patients with primary open angle glaucoma or ocular hypertension.

What clinical trials is 0.01% RO7058584 in?

0.01% RO7058584 has one completed Phase 1 clinical trial, identified as NCT03293992. This study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of the drug following 7 days of eye drop instillation in patients with primary open angle glaucoma or ocular hypertension.

Is 0.01% RO7058584 the same as RO7058584?

Yes, 0.01% RO7058584 is the same drug as RO7058584. The 0.01% refers to the concentration of the drug in the eye drop formulation. The drug is being developed by Roche for the treatment of glaucoma and open-angle glaucoma.