Status:
COMPLETED
SYL040012, Treatment for Open Angle Glaucoma
Lead Sponsor:
Sylentis, S.A.
Conditions:
Open Angle Glaucoma
Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 m...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT02250612
Start Date
October 1 2014
End Date
January 1 2016
Last Update
January 6 2021
Active Locations (21)
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1
Sall Research Medical Center
Artesia, California, United States, 90701
2
North Bay Eye Associates
Petaluma, California, United States, 94954
3
Eye Care Centers Management, Inc (Clayton Eye Center)
Morrow, Georgia, United States, 30260
4
Taustin Eye Center
Louisville, Kentucky, United States, 40217