NCT02250612

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_2

Geographic Reach
3 countries

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 26, 2014

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

November 4, 2020

Completed
Last Updated

January 6, 2021

Status Verified

December 1, 2020

Enrollment Period

10 months

First QC Date

September 5, 2014

Results QC Date

September 15, 2020

Last Update Submit

December 11, 2020

Conditions

Open Angle GlaucomaOcular Hypertension

Keywords

SYL040012bamosiransiRNARNAiGlaucomaOcular hypertension

Outcome Measures

Primary Outcomes (1)

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

    Baseline and Day 28

Secondary Outcomes (2)

  • 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

Study Arms (5)

SYL040012 (bamosiran) 0.375% eye drops

EXPERIMENTAL

1 drop in each eye once daily for 28 consecutive days

Drug: 1 drop of 0.375% SYL040012 (bamosiran)

SYL040012 (bamosiran) 0.750% eye drops

EXPERIMENTAL

1 drop in each eye once daily for 28 consecutive days

Drug: 1 drop of 0.750% SYL040012 (bamosiran)

SYL040012 (bamosiran) 1.125% eye drops

EXPERIMENTAL

1 drop in each eye once daily for 28 consecutive days

Drug: 1 drop of 1.125% SYL040012 (bamosiran)

SYL040012 (bamosiran) 1.5% eye drops

EXPERIMENTAL

1 drop in each eye once daily for 28 consecutive days

Drug: 1 drop of 1.5% SYL040012 (bamosiran)

Timolol maleate 0.5% ophthalmic solution

ACTIVE COMPARATOR

1 drop in each eye twice daily for 28 consecutive days

Drug: 1 drop of 0.5 % timolol maleate

Interventions

1 drop of 0.375% SYL040012 (bamosiran)DRUG
SYL040012 (bamosiran) 0.375% eye drops
1 drop of 0.750% SYL040012 (bamosiran)DRUG
SYL040012 (bamosiran) 0.750% eye drops
1 drop of 1.125% SYL040012 (bamosiran)DRUG
SYL040012 (bamosiran) 1.125% eye drops
1 drop of 1.5% SYL040012 (bamosiran)DRUG
SYL040012 (bamosiran) 1.5% eye drops
1 drop of 0.5 % timolol maleateDRUG
Timolol maleate 0.5% ophthalmic solution

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Sall Research Medical Center

Artesia, California, 90701, United States

Location

North Bay Eye Associates

Petaluma, California, 94954, United States

Location

Eye Care Centers Management, Inc (Clayton Eye Center)

Morrow, Georgia, 30260, United States

Location

Taustin Eye Center

Louisville, Kentucky, 40217, United States

Location

East Tallin Central Hospital

Tallinn, 10138, Estonia

Location

Eye Clinic Dr. Krista Turman

Tallinn, 13419, Estonia

Location

Tartu University Hospital

Tartu, 50406, Estonia

Location

Universitaetsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

University Clinic Magdeburg

Magdeburg, 39106, Germany

Location

Klinikum der Universität München

München, 80336, Germany

Location

Universitätsklinikum Münster

Münster, D-48149, Germany

Location

University Hospital Regensburg

Regensburg, 93053, Germany

Location

Hospital de Torrevieja

Torrevieja, Alicante, 03186, Spain

Location

Hospital de Jerez

Jerez de la Frontera, Cádiz, 11407, Spain

Location

Clinica Universidad Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Clinic

Barcelona, 08036, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario Clínico San Carlos

Madrid, 28040, Spain

Location

Complejo Hospitalario de Pontevedra

Pontevedra, 36001, Spain

Location

Instituto de Oftalmobiología Aplicada

Valladolid, 47011, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular HypertensionGlaucoma

Interventions

Timolol

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesThiadiazolesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorpholinesOxazines

Results Point of Contact

Title
Clinical Trials Department
Organization
Sylentis
info@sylentis.com

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2014

First Posted

September 26, 2014

Study Start

October 1, 2014

Primary Completion

August 1, 2015

Study Completion

January 1, 2016

Last Updated

January 6, 2021

Results First Posted

November 4, 2020

Record last verified: 2020-12

Locations

ES(9)DE(5)US(4)