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

Completed · Phase 1 · Has a placebo group

Conditions studied: Glaucoma, Open-angle, Ocular Hypertension

In brief

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).

Key facts

Study ID

NCT03293992

Run by

Hoffmann-La Roche

People needed

27

Starts

2017-10-10

Expected to finish

2017-12-21

Last updated by the study team

2020-03-31

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

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