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



Status:Completed
Conditions:High Blood Pressure (Hypertension), Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:18 - 90
Updated:3/31/2019
Start Date:October 10, 2017
End Date:December 21, 2017

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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

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).


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
We found this trial at
8
sites
Roswell, Georgia 30076
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Roswell, GA
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Artesia, California 90701
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Artesia, CA
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1675 Aurora Court
Aurora, Colorado 80045
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Aurora, CO
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Austin, Texas 78731
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Austin, TX
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Chandler, Arizona
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Chandler, AZ
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433 North Prairie Avenue
Inglewood, California 90301
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Inglewood, CA
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Morrow, GA
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Newport Beach, California
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Newport Beach, CA
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