View of NCT02250612 on 2014_12_03 .Recruitment Information
Status Recruiting
Start date 2014-10
Last follow-up date 2015-09 (Anticipated)
Primary completion date 2015-07 (Anticipated)
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
Gender Both
Minimum age 18 Years
Healthy volunteers No
Administrative Data
Organization name Sylentis, S.A.
Organization study ID SYL040012_IV
Secondary ID 2013-002947-27 (EudraCT Number)
Sponsor Sylentis, S.A.
Health Authority United States: Food and Drug Administration
Health Authority Spain: Spanish Agency of Medicines
Health Authority Germany: Federal Institute for Drugs and Medical Devices
Health Authority Estonia: The State Agency of Medicine.