Clinical trial NCT02250612: SYL040012, Treatment for Open Angle Glaucoma
Official title: A Phase II, Observer Masked, Active Controlled Study of SYL040012 for the Treatment of Elevated Intraocular Pressure in Patients With Open-angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Open Angle Glaucoma
Ocular Hypertension
Keywords: SYL040012
bamosiran
siRNA
RNAi
Glaucoma
Ocular hypertension
Lead sponsor: Sylentis, S.A.
Sponsor class: INDUSTRY
First posted: 2014-09-26
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change From Baseline in the Mean Diurnal IOP Within Each Treatment Arm
timeFrame: Baseline and Day 28
Secondary outcomes:
measure: Change From Baseline in the Mean Diurnal IOP Within Each Treatment Arm
timeFrame: Baseline and Day 14
measure: Change From Baseline in the Glaucoma Quality of Life Questionnaire (GQL-15) Scores Within Each Treatment Arm
timeFrame: Baseline and Day 29
Other outcomes:
Locations:
city: Artesia
country: United States
facility: Sall Research Medical Center
state: California
city: Petaluma
country: United States
facility: North Bay Eye Associates
state: California
city: Morrow
country: United States
facility: Eye Care Centers Management, Inc (Clayton Eye Center)
state: Georgia
city: Louisville
country: United States
facility: Taustin Eye Center
state: Kentucky
city: Tallin
country: Estonia
facility: East Tallin Central Hospital
city: Tallin
country: Estonia
facility: Eye Clinic Dr. Krista Turman
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg
city: Magdeburg
country: Germany
facility: University Clinic Magdeburg
city: München
country: Germany
facility: Klinikum der Universität München
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Regensburg
country: Germany
facility: University Hospital Regensburg
city: Torrevieja
country: Spain
facility: Hospital de Torrevieja
state: Alicante
city: Jerez de la Frontera
country: Spain
facility: Hospital de Jerez
state: Cádiz
city: Pamplona
country: Spain
facility: Clinica Universidad Navarra
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Clínico San Carlos
city: Pontevedra
country: Spain
facility: Complejo Hospitalario de Pontevedra
city: Valladolid
country: Spain
facility: Instituto de Oftalmobiología Aplicada
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
References: