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
NCT ID: NCT03293992
Last Updated: 2020-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
27 participants
INTERVENTIONAL
2017-10-10
2017-12-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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0.01% RO7058584 or Matching Placebo
0.01% RO7058584
Once daily morning administration for 7 days
Matching Placebo
Once daily morning administration for 7 days
0.1% RO7058584 or Matching Placebo
0.1% RO7058584
Once daily morning administration for 7 days
Matching Placebo
Once daily morning administration for 7 days
1% RO7058584 or Matching Placebo
1% RO7058584
Once daily morning administration for 7 days
Matching Placebo
Once daily morning administration for 7 days
RO7058584 and Latanoprost 0.005%
0.01% RO7058584
Once daily morning administration for 7 days
0.1% RO7058584
Once daily morning administration for 7 days
1% RO7058584
Once daily morning administration for 7 days
Latanoprost 0.005%
Once daily morning or evening dosing
Interventions
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0.01% RO7058584
Once daily morning administration for 7 days
0.1% RO7058584
Once daily morning administration for 7 days
1% RO7058584
Once daily morning administration for 7 days
Matching Placebo
Once daily morning administration for 7 days
Latanoprost 0.005%
Once daily morning or evening dosing
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
90 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Countries
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Other Identifiers
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BP39863
Identifier Type: -
Identifier Source: org_study_id
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