SYL040012, Treatment for Open Angle Glaucoma

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sylentis, S.A.
• Treatments: Maleic acid; Timolol

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