Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
184 participants
INTERVENTIONAL
2014-10-31
2016-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
SYL040012. Tolerance and Effect on Intraocular Pressure in Subjects With Intraocular Pressure (IOP) >= 21 mm Hg
NCT01227291
Dose Finding Clinical Trial With SYL040012 to Evaluate the Tolerability and Effect on Intraocular Pressure in Subjects With Ocular Hypertension or Open Angle Glaucoma
NCT01739244
Phase 2 Study of BL1107 Eye Drops vs. Timolol in Adults With Primary Open Angle Glaucoma or Ocular Hypertension
NCT07168902
Safety and Efficacy of Travoprost/Timolol BAC-free
NCT00760539
Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension
NCT01157364
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SYL040012 (bamosiran) 0.375% eye drops
1 drop in each eye once daily for 28 consecutive days
1 drop of 0.375% SYL040012 (bamosiran)
SYL040012 (bamosiran) 0.750% eye drops
1 drop in each eye once daily for 28 consecutive days
1 drop of 0.750% SYL040012 (bamosiran)
SYL040012 (bamosiran) 1.125% eye drops
1 drop in each eye once daily for 28 consecutive days
1 drop of 1.125% SYL040012 (bamosiran)
SYL040012 (bamosiran) 1.5% eye drops
1 drop in each eye once daily for 28 consecutive days
1 drop of 1.5% SYL040012 (bamosiran)
Timolol maleate 0.5% ophthalmic solution
1 drop in each eye twice daily for 28 consecutive days
1 drop of 0.5 % timolol maleate
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sylentis, S.A.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sall Research Medical Center
Artesia, California, United States
North Bay Eye Associates
Petaluma, California, United States
Eye Care Centers Management, Inc (Clayton Eye Center)
Morrow, Georgia, United States
Taustin Eye Center
Louisville, Kentucky, United States
East Tallin Central Hospital
Tallinn, , Estonia
Eye Clinic Dr. Krista Turman
Tallinn, , Estonia
Tartu University Hospital
Tartu, , Estonia
Universitaetsklinikum Freiburg
Freiburg im Breisgau, , Germany
University Clinic Magdeburg
Magdeburg, , Germany
Klinikum der Universität München
München, , Germany
Universitätsklinikum Münster
Münster, , Germany
University Hospital Regensburg
Regensburg, , Germany
Hospital de Torrevieja
Torrevieja, Alicante, Spain
Hospital de Jerez
Jerez de la Frontera, Cádiz, Spain
Clinica Universidad Navarra
Pamplona, Navarre, Spain
Hospital Clinic
Barcelona, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Universitario Clínico San Carlos
Madrid, , Spain
Complejo Hospitalario de Pontevedra
Pontevedra, , Spain
Instituto de Oftalmobiología Aplicada
Valladolid, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2013-002947-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SYL040012_IV
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.