SYL040012, Treatment for Open Angle Glaucoma (SYLTAG)

Sylentis

Status and phase: Completed; Phase 2

Conditions: Open Angle Glaucoma; Ocular Hypertension

Treatments: Drug: 1 drop of 0.375% SYL040012 (bamosiran); Drug: 1 drop of 1.5% SYL040012 (bamosiran); Drug: 1 drop of 1.125% SYL040012 (bamosiran); Drug: 1 drop of 0.750% SYL040012 (bamosiran); Drug: 1 drop of 0.5 % timolol maleate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02250612

2013-002947-27 (EudraCT Number)

SYL040012_IV

Details and patient eligibility

About

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.

Enrollment: 184 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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184 participants in 5 patient groups

SYL040012 (bamosiran) 0.375% eye drops

Experimental group

Description:

1 drop in each eye once daily for 28 consecutive days

Treatment:

Drug: 1 drop of 0.375% SYL040012 (bamosiran)

SYL040012 (bamosiran) 0.750% eye drops

Experimental group

Description:

1 drop in each eye once daily for 28 consecutive days

Treatment:

Drug: 1 drop of 0.750% SYL040012 (bamosiran)

SYL040012 (bamosiran) 1.125% eye drops

Experimental group

Description:

1 drop in each eye once daily for 28 consecutive days

Treatment:

Drug: 1 drop of 1.125% SYL040012 (bamosiran)

SYL040012 (bamosiran) 1.5% eye drops

Experimental group

Description:

1 drop in each eye once daily for 28 consecutive days

Treatment:

Drug: 1 drop of 1.5% SYL040012 (bamosiran)

Timolol maleate 0.5% ophthalmic solution

Active Comparator group

Description:

1 drop in each eye twice daily for 28 consecutive days

Treatment:

Drug: 1 drop of 0.5 % timolol maleate