SYL040012, Treatment for Open Angle Glaucoma

Completed · Phase 2

Conditions studied: Open Angle Glaucoma, Ocular Hypertension

In brief

The purpose of this double-masked, randomized, controlled study is to assess the safety and ocular hypotensive efficacy of four different doses of SYL040012 (bamosiran) eye drops compared to Timolol maleate 0.5% after 28 treatment days in patients with elevated intraocular pressure.

Key facts

Study ID

NCT02250612

Run by

Sylentis, S.A.

People needed

184

Starts

2014-10-01

Expected to finish

2016-01-01

Last updated by the study team

2021-01-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients older than 18 years of either sex
• Good or fair general health as assessed by the investigator.
• Signed informed consent prior to any clinical trial-related procedures
• Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT)
• Post-washout mean IOP above target range
• BCVA 1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200)
• Stable visual field
• Central corneal thickness 480-620 μm
• Shaffer gonioscopic grade of ≥ 3 (in at least 3 quadrants) in both eyes

You may not qualify if…

• Pregnant or breastfeeding females
• Females of childbearing potential not willing to use a medically acceptable contraceptive method
• Clinically significant systemic disease
• Changes of systemic medication that could have a substantial effect on IOP
• Known hypersensitivity to any component of the formulations
• Unable to comply with the clinical trial requirements
• Clinically significant abnormalities in laboratory tests
• Severe visual field defect
• Any secondary glaucoma
• Pseudoexfoliation or pigment dispersion component, history of angle closure or narrow angles.
• IOP ≥ 35 mm Hg in any eye
• Previous non-laser glaucoma surgery or glaucoma laser procedures (e.g., laser trabeculoplasty) and refractive surgery
• Any ocular surgery or laser treatment, cataract extraction or ocular trauma within 6 months prior to Baseline
• Evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis at baseline (Visit 0), or a history of herpes simplex keratitis
• Clinically significant ocular disease

Where it is running

• Sall Research Medical Center — Artesia, California, United States
• North Bay Eye Associates — Petaluma, California, United States
• Eye Care Centers Management, Inc (Clayton Eye Center) — Morrow, Georgia, United States
• Taustin Eye Center — Louisville, Kentucky, United States
• East Tallin Central Hospital — Tallinn, Estonia
• Eye Clinic Dr. Krista Turman — Tallinn, Estonia
• Tartu University Hospital — Tartu, Estonia
• Universitaetsklinikum Freiburg — Freiburg im Breisgau, Germany
• University Clinic Magdeburg — Magdeburg, Germany
• Klinikum der Universität München — München, Germany
• Universitätsklinikum Münster — Münster, Germany
• University Hospital Regensburg — Regensburg, Germany
• Hospital de Torrevieja — Torrevieja, Alicante, Spain
• Hospital de Jerez — Jerez de la Frontera, Cádiz, Spain
• Clinica Universidad Navarra — Pamplona, Navarre, Spain
• Hospital Clinic — Barcelona, Spain
• Hospital Universitario Ramón y Cajal — Madrid, Spain
• Hospital Universitario Clínico San Carlos — Madrid, Spain
• Complejo Hospitalario de Pontevedra — Pontevedra, Spain
• Instituto de Oftalmobiología Aplicada — Valladolid, Spain
• Hospital Universitario Miguel Servet — Zaragoza, Spain

Full record on ClinicalTrials.gov

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