dose finding clinical trial with syl040012 to evaluate the tolerability and effect on intraocular pressure in subjects with ocular hypertension or open angle glaucoma

Conditions: Ocular Hypertension; Open Angle Glaucoma

Summary: the aim of this dose-finding clinical trial is to evaluate the systemic tolerability, local tolerability and intraocular pressure lowering effect of three different doses of syl040012 in subjects with ocular hypertension or open-angle glaucoma.


Eligibility criteria:
inclusion criteria: * subjects must provide signed informed consent prior to participation in any study-related procedures. * male and female subjects in good or fair general health as assessed by the investigator. * ≥18 years of age. * previous history or newly diagnosed elevated iop (≥21 mmhg) with or without open-angle glaucoma in both eyes. * normal result, or result typical for open-angle glaucoma of the following assessments in both eyes or available results in writing within the last 3 months prior to baseline period i.e. up to 4 months before day 1, on condition that no new ocular signs or symptoms (e.g. marked deterioration of vision, eye pain) has occurred since then which would justify a repeat examination: * visual field 24-2 or equivalent * optical coherence tomography (oct) * best corrected visual acuity ≥0.5 (20/40) on the snellen chart, or ≤ 0.3 logmar * schirmer test (lacrimation) * funduscopy exclusion criteria: * pregnant or breastfeeding females or those with a positive pregnancy test. females of childbearing potential who will not use a medically acceptable contraceptive method from selection and during the hole study. * females of childbearing potential not willing to use a medically acceptable contraceptive method from enrolment until after the follow-up visit. * any current disease or condition that might compromise the respiratory, cardiovascular, endocrine, neurological, haematological, renal, or gastrointestinal function. * previous chronic processes or with rebound characteristics that could interfere with the study according to the investigator's judgment. * body temperature. * intolerability of any components of syl040012 or placebo. * unable to comply with the clinical trial requirements as judged by the investigator. * beta blockers or corticosteroids use (other than cutaneous or intra-articular) for the treatment of concurrent diseases, even if sporadically, or any ocular or nasal vasoconstrictor treatment in the last 15 days prior to the first investigational product administration * previous refractive surgery; cataract extraction in the last 6 months * previous surgery for glaucoma. * participation in a clinical trial within 2 months before the enrolment visit * use of any other investigational product within 60 days before the enrolment visit. * other drugs for the treatment of concurrent diseases are allowed. however, their dosages should be kept constant throughout the study. * use of contact lenses in the last 7 days prior to the first investigational product administration and wearing contact lenses throughout the trial * history of ocular infection or inflammation within the last 3 months before the enrolment visit * angle-closure or pigmentary glaucoma. * chronic or current acute eye diseases such as scleritis, uveitis, blepharitis, conjunctivitis, or ocular herpes simplex virus infection

Keywords: glaucoma open angle glaucoma ocular hypertension iop rnai sirna beta inhibitor