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

NCT03293992 | Completed Phase 1 FDA Drug

• 1 other identifier: BP39863
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 8

Brief Summary

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).

Conditions

Glaucoma, Open-angle; Ocular Hypertension

Outcome Measures

Primary Outcomes (6)

• 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 (5)

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

  7 days

• Cmax of RO7058584

  Up to Day 8

• Tmax of RO7058584

  Up to Day 8

• Ctrough of RO7058584

  Up to Day 8

• AUC0-24h of RO7058584

  Up to Day 8

Study Arms (4)

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%

Interventions

0.01% RO7058584 DRUG

Once daily morning administration for 7 days

0.01% RO7058584 or Matching Placebo; RO7058584 and Latanoprost 0.005%

0.1% RO7058584 DRUG

Once daily morning administration for 7 days

0.1% RO7058584 or Matching Placebo; RO7058584 and Latanoprost 0.005%

1% RO7058584 DRUG

Once daily morning administration for 7 days

1% RO7058584 or Matching Placebo; RO7058584 and Latanoprost 0.005%

Matching Placebo DRUG

Once daily morning administration for 7 days

0.01% RO7058584 or Matching Placebo; 0.1% RO7058584 or Matching Placebo; 1% RO7058584 or Matching Placebo

Latanoprost 0.005% DRUG

Once daily morning or evening dosing

RO7058584 and Latanoprost 0.005%

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (8)

Arizona Eye Center

Chandler, Arizona, 85225, United States

Location

Sall Research Medical Center

Artesia, California, 90701, United States

Location

United Med Res Inst

Inglewood, California, 90301, United States

Location

Eye research foundation

Newport Beach, California, 92663, United States

Location

Rocky Mountain Lions Eye Inst

Aurora, Colorado, 80045, United States

Location

Eye Care Centers Management, Inc. (Clayton Eye Center)

Morrow, Georgia, 30260, United States

Location

Coastal Research Associates

Roswell, Georgia, 30076, United States

Location

Texan Eye/Keystone Research

Austin, Texas, 78731, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: September 26, 2017
• Study Start: October 10, 2017
• Primary Completion: December 15, 2017
• Study Completion: December 21, 2017
• Last Updated: March 31, 2020

Record last verified: 2020-03

Locations

US (8)