Clinical trial NCT01739244 (phase 2, status: completed)
Conditions: ocular hypertension, open angle glaucoma
ICD codes: H40.053, H40.051, H40.052, H40.059, H40.10X0, H40.10X1, H40.10X2, H40.10X3, H40.10X4, H40.1130, H40.1131
Drugs: syl040012, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
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