A Study of the Safety, Tolerability, Pharmacokinetics, an... | NCT03293992

NCT03293992

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
0.01% RO7058584 or Matching Placebo	Experimental	Drug: 0.01% RO7058584 Drug: Matching Placebo
0.1% RO7058584 or Matching Placebo	Experimental	Drug: 0.1% RO7058584 Drug: Matching Placebo
1% RO7058584 or Matching Placebo	Experimental	Drug: 1% RO7058584 Drug: Matching Placebo
RO7058584 and Latanoprost 0.005%	Experimental	Drug: 0.01% RO7058584 Drug: 0.1% RO7058584 Drug: 1% RO7058584 Drug: Latanoprost 0.005%

Name	Type	Description	Arm Group Labels	Other Names
0.01% RO7058584	Drug	Once daily morning administration for 7 days	0.01% RO7058584 or Matching Placebo RO7058584 and Latanoprost 0.005%

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Up to 12 weeks
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	IOP will be assessed by Goldman Applanation tonometry.	7 days

Secondary Outcomes

Measure	Description	Time Frame
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	7 days
Cmax of RO7058584

Eligibility Module

Eligibility Criteria

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 who are able to safely stop their Intraocular pressure (IOP)-lowering medication(s) prior to randomization according to the required minimum washout periods
At baseline visit, IOP ≥ 24 millimeters of mercury (mmHg) in the morning (8:00 AM ± 1h) and ≥ 22 mmHg in the afternoon (2:00 PM ± 1h) measurement in the same eye and ≤ 34 mmHg at all timepoints in both eyes
Best corrected logarithm of the minimum angle of resolution (logMAR) visual acuity score of 0.7 or better in each eye as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity test at screening
Central corneal thickness (pachymetry) measurement 450 to 620 micrometers (μm) in both eyes at screening
Cup-to-disc ratio ≤ 0.8 (both eyes) at screening
Anterior chamber angle is open and non-occludable (both eyes) as confirmed by the investigator by gonioscopy examination at screening

Exclusion Criteria:

Advanced visual field defects
Other forms of glaucoma than POAG or OHT
Any abnormality preventing reliable applanation tonometry
Any clinically significant corneal scarring, haze or opacity
Uncooperativeness of the participant that restricts adequate examination of IOP, ocular fundus or anterior chamber
Any presence or history of uveitis or other history of any ocular inflammatory disease.
History or signs of penetrating ocular trauma
Risk of visual field or visual acuity worsening in either eye as a consequence of glaucoma progression or consequence of participation in the trial or any other ocular disease, according to the investigator's best judgment
History of any glaucoma surgery
History of refractive surgery
Any other intra-ocular surgery within six months of screening
Any active ocular disease requiring treatment.
Use of any listed prohibited medications
Current enrollment or past participation within the last 30 days before the screening visit in any other clinical study involving an investigational study treatment or any other type of medical research
Any participant who is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff thereof, directly involved in the conduct of the protocol

Facility	Status	City	State	ZIP	Country	Contacts
Arizona Eye Center		Chandler	Arizona	85225	United States
Sall Research Medical Center

ID	Term
D005902	Glaucoma, Open-Angle
D009798	Ocular Hypertension

ID	Term
D005901	Glaucoma
D005128	Eye Diseases