Phase 2
Completed N=184
SYL040012, Treatment for Open Angle Glaucoma
Source: ClinicalTrials.gov NCT02250612 ↗Enrolled (actual)
184
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcomePrimary: Change From Baseline in the Mean Diurnal IOP Within Each Treatment Arm — -2.4; -3.2; -3.1; -3.1 mmHg — p=0.93
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Mean Diurnal IOP Within Each Treatment Arm |
-2.4; -2.9; -2.5; -2.4; -5.8 | 0.94 |
| SECONDARY Change From Baseline in the Mean Diurnal IOP Within Each Treatment Arm |
-2.4; -2.9; -2.5; -2.4; -5.8 | 0.94 |
| SECONDARY Change From Baseline in the Glaucoma Quality of Life Questionnaire (GQL-15) Scores Within Each Treatment Arm |
20; 20.7; 19.4; 22; 18.7 | — |
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
Data sourced from ClinicalTrials.gov (NCT02250612). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.