SYL040012, Treatment for Open Angle Glaucoma

Phase 2

Completed

• Conditions: Open Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: 1 drop of 0.5 % timolol maleate; Drug: 1 drop of 0.375% SYL040012 (bamosiran); Drug: 1 drop of 0.750% SYL040012 (bamosiran); Drug: 1 drop of 1.125% SYL040012 (bamosiran); Drug: 1 drop of 1.5% SYL040012 (bamosiran)

• Registration Number: NCT02250612
• Lead Sponsor: Sylentis, S.A.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-05
• Study First Submitted QC: 2014-09-24
• Study First Posted: 2014-09-26
• Study Start: 2014-10
• Primary Completion: 2015-08
• Study Completion: 2016-01
• Results First Submitted: 2020-09-15
• Results First Submitted QC: 2020-10-09
• Results First Posted: 2020-11-04
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2021-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Timolol maleate 0.5% ophthalmic solution	1 drop of 0.5 % timolol maleate	1 drop in each eye twice daily for 28 consecutive days
SYL040012 (bamosiran) 0.375% eye drops	1 drop of 0.375% SYL040012 (bamosiran)	1 drop in each eye once daily for 28 consecutive days
SYL040012 (bamosiran) 0.750% eye drops	1 drop of 0.750% SYL040012 (bamosiran)	1 drop in each eye once daily for 28 consecutive days
SYL040012 (bamosiran) 1.125% eye drops	1 drop of 1.125% SYL040012 (bamosiran)	1 drop in each eye once daily for 28 consecutive days
SYL040012 (bamosiran) 1.5% eye drops	1 drop of 1.5% SYL040012 (bamosiran)	1 drop in each eye once daily for 28 consecutive days

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Mean Diurnal IOP Within Each Treatment Arm	Baseline and Day 28

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in the Mean Diurnal IOP Within Each Treatment Arm	Baseline and Day 14
Change From Baseline in the Glaucoma Quality of Life Questionnaire (GQL-15) Scores Within Each Treatment Arm	Baseline and Day 29	The GQL-15 is a 15 item, 4-domain tool. GQL-15 scoring ranges from 0 to 75. Higher scores indicate poorer quality of life.

Trial Locations

Locations (21)

Clinica Universidad Navarra; 🇪🇸 Pamplona, Navarra, Spain

Eye Clinic Dr. Krista Turman; 🇪🇪 Tallin, Estonia

Hospital de Torrevieja; 🇪🇸 Torrevieja, Alicante, Spain

University Clinic Magdeburg; 🇩🇪 Magdeburg, Germany

University Hospital Regensburg; 🇩🇪 Regensburg, Germany

Klinikum der Universität München; 🇩🇪 München, Germany

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain

East Tallin Central Hospital; 🇪🇪 Tallin, Estonia

Sall Research Medical Center; 🇺🇸 Artesia, California, United States

Tartu University Hospital; 🇪🇪 Tartu, Estonia

North Bay Eye Associates; 🇺🇸 Petaluma, California, United States

Universitaetsklinikum Freiburg; 🇩🇪 Freiburg, Germany

Hospital de Jerez; 🇪🇸 Jerez de la Frontera, Cádiz, Spain

Hospital Universitario Clínico San Carlos; 🇪🇸 Madrid, Spain

Instituto de Oftalmobiología Aplicada; 🇪🇸 Valladolid, Spain

Universitätsklinikum Münster; 🇩🇪 Münster, Germany

Complejo Hospitalario de Pontevedra; 🇪🇸 Pontevedra, Spain

Eye Care Centers Management, Inc (Clayton Eye Center); 🇺🇸 Morrow, Georgia, United States

Hospital Clinic; 🇪🇸 Barcelona, Spain

Hospital Universitario Miguel Servet; 🇪🇸 Zaragoza, Spain

Taustin Eye Center; 🇺🇸 Louisville, Kentucky, United States