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OpenTrials
Completed

NCT Number: NCT03293992

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

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).

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Arizona Eye Center, Chandler, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.01% RO7058584

Drug

Once daily morning administration for 7 days

0.1% RO7058584

Drug

Once daily morning administration for 7 days

1% RO7058584

Drug

Once daily morning administration for 7 days

Matching Placebo

Drug

Once daily morning administration for 7 days

Latanoprost 0.005%

Drug

Once daily morning or evening dosing

Primary outcomes

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

    Time frame: 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.

  2. Incidence of Abnormal Laboratory Findings

    Time frame: Up to 12 weeks

  3. Incidence of Blood Pressure Abnormalities

    Time frame: Up to 12 weeks

  4. Incidence of Pulse Rate Abnormalities

    Time frame: Up to 12 weeks

  5. Incidence of Electrocardiogram (ECG) Findings

    Time frame: Up to 12 weeks

  6. Change From Baseline in Mean Intraocular pressure (IOP) After 7 Days of Study Drug Administration

    Time frame: 7 days

    IOP will be assessed by Goldman Applanation tonometry.

Secondary outcomes

  1. Change From Baseline in Mean Intraocular pressure (IOP) at Matched Clock-Times After 7 Days of Study Drug Administration

    Time frame: 7 days

    IOP will be assessed by Goldmann Applanation tonometry

  2. Cmax of RO7058584

    Time frame: Up to Day 8

    Cmax is the maximum observed plasma concentration.

  3. Tmax of RO7058584

    Time frame: Up to Day 8

    Tmax is the time to maximum observed plasma concentration.

  4. Ctrough of RO7058584

    Time frame: Up to Day 8

    Ctrough is the concentration at the end of a dosing interval before the next dose administration.

  5. AUC0-24h of RO7058584

    Time frame: Up to Day 8

    AUC0-24h is the area under the plasma concentration versus time curve (AUC) from Time 0 to 24 h post-dose.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 26, 2017
Registry last updated
Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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