SYL040012, Treatment for Open Angle Glaucoma

Ocular Hypertension Clinical Trial

— SYLTAG  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02250612
• Other study ID #: SYL040012_IV
• Secondary ID: 2013-002947-27
• Status: Completed
• Phase: Phase 2
• Start date: October 2014
• Est. completion date: January 2016

Study information

• Verified date: December 2020
• Source: Sylentis, S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: January 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open Angle Glaucoma

Intervention

Drug:
• 1 drop of 0.375% SYL040012 (bamosiran)

• 1 drop of 0.750% SYL040012 (bamosiran)

• 1 drop of 1.125% SYL040012 (bamosiran)

• 1 drop of 1.5% SYL040012 (bamosiran)

• 1 drop of 0.5 % timolol maleate

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sylentis, S.A.

Countries where clinical trial is conducted

United States,  Estonia,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in the Mean Diurnal IOP Within Each Treatment Arm		Baseline and Day 28
Secondary	Change From Baseline in the Mean Diurnal IOP Within Each Treatment Arm		Baseline and Day 14
Secondary	Change From Baseline in the Glaucoma Quality of Life Questionnaire (GQL-15) Scores Within Each Treatment Arm	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.	Baseline and Day 29