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

Roche

Status and phase: Completed; Phase 1

Conditions: Ocular Hypertension; Glaucoma, Open-angle

Treatments: Drug: Matching Placebo; Drug: 1% RO7058584; Drug: 0.1% RO7058584; Drug: 0.01% RO7058584; Drug: Latanoprost 0.005%

Study type: Interventional

Funder types: Industry

Identifiers

NCT03293992

BP39863

Details and patient eligibility

About

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).

Enrollment: 27 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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27 participants in 4 patient groups

0.01% RO7058584 or Matching Placebo

Experimental group

Treatment:

Drug: 0.01% RO7058584

Drug: Matching Placebo

0.1% RO7058584 or Matching Placebo

Experimental group

Treatment:

Drug: 0.1% RO7058584

Drug: Matching Placebo

1% RO7058584 or Matching Placebo

Experimental group

Treatment:

Drug: Matching Placebo

Drug: 1% RO7058584

RO7058584 and Latanoprost 0.005%

Experimental group

Treatment:

Drug: 0.1% RO7058584

Drug: Latanoprost 0.005%

Drug: 0.01% RO7058584

Drug: 1% RO7058584