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SYL040012, Treatment for Open Angle Glaucoma (SYLTAG)

Primary Purpose

Open Angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
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
Sponsored by
Sylentis, S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open Angle Glaucoma focused on measuring SYL040012, bamosiran, siRNA, RNAi, Glaucoma, Ocular hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Sall Research Medical Center
  • North Bay Eye Associates
  • Eye Care Centers Management, Inc (Clayton Eye Center)
  • Taustin Eye Center
  • East Tallin Central Hospital
  • Eye Clinic Dr. Krista Turman
  • Tartu University Hospital
  • Universitaetsklinikum Freiburg
  • University Clinic Magdeburg
  • Klinikum der Universität München
  • Universitätsklinikum Münster
  • University Hospital Regensburg
  • Hospital de Torrevieja
  • Hospital de Jerez
  • Clinica Universidad Navarra
  • Hospital Clinic
  • Hospital Universitario Ramón y Cajal
  • Hospital Universitario Clínico San Carlos
  • Complejo Hospitalario de Pontevedra
  • Instituto de Oftalmobiología Aplicada
  • Hospital Universitario Miguel Servet

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

SYL040012 (bamosiran) 0.375% eye drops

SYL040012 (bamosiran) 0.750% eye drops

SYL040012 (bamosiran) 1.125% eye drops

SYL040012 (bamosiran) 1.5% eye drops

Timolol maleate 0.5% ophthalmic solution

Arm Description

1 drop in each eye once daily for 28 consecutive days

1 drop in each eye once daily for 28 consecutive days

1 drop in each eye once daily for 28 consecutive days

1 drop in each eye once daily for 28 consecutive days

1 drop in each eye twice daily for 28 consecutive days

Outcomes

Primary Outcome Measures

Change From Baseline in the Mean Diurnal IOP Within Each Treatment Arm

Secondary Outcome Measures

Change From Baseline in the Mean Diurnal IOP Within Each Treatment Arm
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.

Full Information

First Posted
September 5, 2014
Last Updated
December 11, 2020
Sponsor
Sylentis, S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT02250612
Brief Title
SYL040012, Treatment for Open Angle Glaucoma
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sylentis, S.A.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma, Ocular Hypertension
Keywords
SYL040012, bamosiran, siRNA, RNAi, Glaucoma, Ocular hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
184 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SYL040012 (bamosiran) 0.375% eye drops
Arm Type
Experimental
Arm Description
1 drop in each eye once daily for 28 consecutive days
Arm Title
SYL040012 (bamosiran) 0.750% eye drops
Arm Type
Experimental
Arm Description
1 drop in each eye once daily for 28 consecutive days
Arm Title
SYL040012 (bamosiran) 1.125% eye drops
Arm Type
Experimental
Arm Description
1 drop in each eye once daily for 28 consecutive days
Arm Title
SYL040012 (bamosiran) 1.5% eye drops
Arm Type
Experimental
Arm Description
1 drop in each eye once daily for 28 consecutive days
Arm Title
Timolol maleate 0.5% ophthalmic solution
Arm Type
Active Comparator
Arm Description
1 drop in each eye twice daily for 28 consecutive days
Intervention Type
Drug
Intervention Name(s)
1 drop of 0.375% SYL040012 (bamosiran)
Intervention Type
Drug
Intervention Name(s)
1 drop of 0.750% SYL040012 (bamosiran)
Intervention Type
Drug
Intervention Name(s)
1 drop of 1.125% SYL040012 (bamosiran)
Intervention Type
Drug
Intervention Name(s)
1 drop of 1.5% SYL040012 (bamosiran)
Intervention Type
Drug
Intervention Name(s)
1 drop of 0.5 % timolol maleate
Primary Outcome Measure Information:
Title
Change From Baseline in the Mean Diurnal IOP Within Each Treatment Arm
Time Frame
Baseline and Day 28
Secondary Outcome Measure Information:
Title
Change From Baseline in the Mean Diurnal IOP Within Each Treatment Arm
Time Frame
Baseline and Day 14
Title
Change From Baseline in the Glaucoma Quality of Life Questionnaire (GQL-15) Scores Within Each Treatment Arm
Description
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.
Time Frame
Baseline and Day 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Sall Research Medical Center
City
Artesia
State/Province
California
ZIP/Postal Code
90701
Country
United States
Facility Name
North Bay Eye Associates
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Facility Name
Eye Care Centers Management, Inc (Clayton Eye Center)
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
Taustin Eye Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
East Tallin Central Hospital
City
Tallin
ZIP/Postal Code
10138
Country
Estonia
Facility Name
Eye Clinic Dr. Krista Turman
City
Tallin
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Tartu University Hospital
City
Tartu
ZIP/Postal Code
50406
Country
Estonia
Facility Name
Universitaetsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
University Clinic Magdeburg
City
Magdeburg
ZIP/Postal Code
39106
Country
Germany
Facility Name
Klinikum der Universität München
City
München
ZIP/Postal Code
80336
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
ZIP/Postal Code
D-48149
Country
Germany
Facility Name
University Hospital Regensburg
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Hospital de Torrevieja
City
Torrevieja
State/Province
Alicante
ZIP/Postal Code
03186
Country
Spain
Facility Name
Hospital de Jerez
City
Jerez de la Frontera
State/Province
Cádiz
ZIP/Postal Code
11407
Country
Spain
Facility Name
Clinica Universidad Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Clinic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Complejo Hospitalario de Pontevedra
City
Pontevedra
ZIP/Postal Code
36001
Country
Spain
Facility Name
Instituto de Oftalmobiología Aplicada
City
Valladolid
ZIP/Postal Code
47011
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

SYL040012, Treatment for Open Angle Glaucoma

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