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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
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Eye Disorder -
Intraocular Pressure -
Glaucoma
- For Medical Professional
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Basic Details
Sponsor
Hoffmann-La Roche
Phase
Phase 1
Study Identifier
NCT03293992, BP39863
Condition
Glaucoma, Open-angle, Ocular Hypertension
Official 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
Study 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).
Eligibility Criteria
All
≥ 18 Years & ≤ 90 Years
No
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
This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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For the latest version of this information please go to www.forpatients.roche.com